Collect and inspect injection molded plastic parts
Will operate highly sophisticated metrology equipment and instrumentation, including Interferometers, surface profilometers, CT Scanners and other metrology equipment utilized in the manufacturing of Intraocular Lenses.
Computes and analyzes test data.
Prepares reports on findings and makes recommendations.
Performs experimental testing procedures and suggests changes to increase the validity and reliability of results.
Fluency in English Essential
Eight years of applicable laboratory experience
Experience operating sophisticated metrology equipment (White Light Interferometer, Surface Profilometer, CT Scanner and Vision Systems) required.
Experience of operating metrology equipment;
Working knowledge of MS Office and MS Excel
Source: Job Diva – Job Listing
Source: Job Diva – Job Listing
1st or 2nd shift ( 1st shift: 7 am – 4 pm / 2nd shift: 2pm-11pm, either Tues-Sat or Sun-Thurs)
Provide support for QC Chemistry analytical prelim, finished product and stability testing
Perform laboratory activities to support product testing Review laboratory data
The ability to work independently following an approved protocol
The ability to function in a team enviornment
The flexibility to work overtime as required by the aggressive project schedule
Good technical writing skills and the ability to communicate technical issues to project lead and team
Proficient in MS Word and excel
Source: Job Diva – Job Listing
Duties:
This position supports North America Scientific Purchasing with contract coordinating for new contracts and change orders including contract planning, preparation, and follow-up for services pertaining to clinical studies Phase I through Phase IV.
The position receives contract requests and works to understand customer requirements, processes request forms with Legal, maintains follow-up on contracts and works to resolve issues.
The position will monitor the quality of data and the compliance of the purchasing project files following Scientific Purchasing procedures.
Experience: 3 to 6 years.
Skills: Must have contracting experience. Paralegal a plus.
Education: Must have Bachelor's Degree
Source: Job Diva – Job Listing
The Manufacturing Engineer will lead, execute, document & manage the validation and development activities necessary to support the introduction or revision of production equipment and processes. In addition, the engineer is responsible for assisting or leading process development on the equipment and assisting vendors with equipment integration. As part of this effort, the engineer will assist at times with troubleshooting and corrective actions within production equipment. Basic understanding of PLC programming and functionality, Adept or Motoman robot functionality, statistical process control, Cognex vision systems, pneumatic test systems, and Kinetex Servo programming and use is a plus, but not required.
The Manufacturing Engineer will support the Site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies' requirements and related SOPs. The Manufacturing Engineer will be responsible to provide guidance in the translation of critical process parameters and the process control strategy into a focused validation plan for process and equipment validations.
Manufacturing Engineers will understand and apply the concepts of Continuous Monitoring to ensure that processes that have been transferred into production are being monitoring & controlled appropriately to maintain the equipment in a validated state. Hands-on support of manufacturing equipment before, during, and after release is expected. Efficiency of process design both from an equipment and overall manufacturing process view is also a key deliverable.
Source: Job Diva – Job Listing
The Associate Clinical Development Director (Assoc. CDD) is responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data. May be responsible for the clinical and scientific strategy of assigned sections of a clinical development program, depending on the size and complexity
Major Activities
1) Provides clinical leadership, medical and scientific strategic input, and contributes to development of trial related documents (e.g., CTPs, informed consent form, case report forms, data monitoring committee charters, data analysis plan, reports, publications) for assigned clinical trial(s) consistent with Integrated Development Plan (IDP); develops materials for trial-related advisory boards, data monitoring committees, investigator meetings, and protocol training meetings for *** local medical organizations
2) Provides clinical and scientific input and contributes to clinical sections of trial and program level regulatory documents (e.g., Investigators Brochures, Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities)
3) In collaboration with appropropriate Clinical Trial Team (CTT) members:
a) Ensures clinical support of trials as needed
b) Conducts ongoing medical and scientific review of clinical trial data with Clincal Scientific Expert(s) with appropriate oversight from Medical Lead
c) Manages patient safety reports on trial data to safety and clinical boards (e.g., Safety Management Team (SMT), GCT, GPT) with appropriate oversight from Medical Lead
d) Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations
4) Supports Therapeutic Area Head (TAH) with contributing to peer-review of IDPs, CTPs, and other clinical documents across various indications and programs
5) Supports development of TA strategies, as needed
6) May contribute to the medical and scientific evaluation for Business Development & Licensing (Client&L) opportunities
7) Contributes to talent and career development of CD associates through on-boarding, coaching, and/or mentoring support; develops and fosters CD culture; and may contribute to the performance evaluation of CTT members
8) Contributes to medical/scientific training of relevant *** stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training
9) Contributes to global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)
= 3 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. = 2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
Demonstrated ability to establish effective working relationship with key investigators
Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes'
Strong communication skills, written and oral
Strong interpersonal skills
Strong negotiation and conflict resolution skills
Source: Job Diva – Job Listing
Summary:
The Quality Specialist will work in the Quality Assurance Department to support Supplier Management team.
Duties:
Investigation of Supplier Corrective Action Requests (SCARs)
Investigate issues associated with purchased materials
Work with suppliers to identify corrective actions to prevent reoccurrence
Processing of Supplier Change Notifications (SCNs)
Review of supplier change notification against Approved Supplier List to determine if material is used at Ridgefield
Routing SCN for assessment to appropriate subject matter experts
Facilitate SCN meetings for significant changes to determine actions required
Create works in Phenix SCN workflow for actions required
Sending out periodic reports of open works to work owners and department managers
Compiling SCN metrics and following up with responsible parties
Writing Quality Agreements
Required:
Bachelor’s degree in either Biology, Chemistry, or other life science
Minimum of 5 years of experience working in Quality in Pharmaceutical or Medical Device Company
Preferred Experience:
Experience working in Supplier Quality or Investigations
Source: Job Diva – Job Listing
Duties:
– Designs experimental plan to support project objectives.
– Executes bench experiments; makes detailed and general observations and analyzes data.
– Prepares technical reports, summaries and quantitative analyses.
– Maintains complete and accurate records.
– Normally acts independently for developing methods, techniques and evaluation criteria for obtaining results.
– Identifies and implements improvements to work processes and laboratory environment.
– Recognized expert across a wide range of techniques and their application.
– Recognizes and documents activities for publication and/or patent potential.
– May participate in scientific conferences and contribute to scientific journals.
– Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables.
– Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
– Participates or leads cross functional technical teams such as a failure investigation or core team.
– Works well in a team environment by being a productive project team member, suggesting creative solutions to problems and providing input to project planning.
– Troubleshoots problems and institutes corrective action.
– Prepares and presents experimental procedures and results in group and project teams.
Source: Job Diva – Job Listing
Responsible for conducting research, development and manufacturing laboratory experimentation and other scientific activities to support Client projects. Exercises technical expertise and discretion in the design, execution and interpretation of experiments that contribute to project strategies. Prepares technical reports, summaries, protocols and quantitative analyses. Presents and discusses results of experiments within department and project team. Maintains high level of professional expertise through familiarity with scientific literature and may participate in conferences and professional societies. Follows company policies and procedures for GMP, GLP, Design Control and others as appropriate. Maintains complete and accurate laboratory documentation and electronic files. May act as principal investigator in conducting own experiments. Designs a wide range of experimental protocols. Executes bench experiments; makes detailed and general observations and analyzes data. Prepares technical reports, summaries and quantitative analyses. Maintains complete and accurate records. Normally receives general directions on routine and new assignments. Identifies and implements improvements to work processes and laboratory environment. Recognized expert for area of expertise. Recognizes and documents activities for publication and/or patent potential. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Participates in cross functional technical teams such as a failure investigation or core team. Works well in a team environment by being a productive project team member, suggesting creative solutions to problems and providing input to project planning. Establishes interfaces across other organizational groups. Trains others in areas of expertise. Troubleshoots problems and institutes corrective action. Prepares and presents experimental procedures and results in group and project teams. Monitors work to ensure quality, and continuously promote Quality First Time.
Knows wide range of experimental techniques and skilled in their applications. Capable with searching scientific literature to gain general and specific information. Skilled with use of word processing, spreadsheets, graphical and presentation software applications.
Experience: 4 or more years relevant job experience.
Source: Job Diva – Job Listing
The Technical Writer will be responsible for attending all manufacturing meetings with various manufacturing team leads including Planning, Production, Warehouse and Quality. During these meeting he or she will be tasked with documenting all discussion on changes to existing Standard Operating Procedures (SOP) and New SOPs. This individual will then refer to their notes from the meeting in order to update existing SOPs and or create new SOPs.Responsibilities:Creates or edits standard operating procedures for *** business processes.Manages document change process to support process improvements. Creates or edits process flow diagrams.Creates or edits training documentation. Submits new documentation revisions into the document control system and tracks them to release.
Quals–
Bachelors degree in Science or Engineering Minimum of 2 years of technical writing in a scientific discipline writing skills need to be strong Experience in a pharmaceutical manufacturing environment is preferred – this individual needs to be able to ask questions and be knowledgeable of a standard manufacturing process.
Source: Job Diva – Job Listing
We are looking for a savvy Test Engineer to work with our engineering team on developing automated test systems and suites to develop, maintain and support automated testing of production software and application releases. This role will focus on developing in house tools for automation as well as managing production test automation.
Responsibilities
Take full ownership for test engineering systems, processes and automation.
Work with our QA Engineer to design, develop and maintain functional, regression, integration and end-to-end tests
Contribute to developing, debugging and maintaining production test firmware and software
Contribute to developing and running system validation tests to verify and validate software releases (across different combinations of firmware and backend software)
Provide timely feedback on feature functionality, validity and product defects
Triage bugs submitted from users and other teammates, verifying issues and gathering additional details.
Be a team player in a small, flat, highly collaborative environment, working closely with engineering teams.
Skills and Expertise
Expert in automated testing across multiple platforms and testing techniques
Experience with Python or another automation scripting language
Advanced level of Jira/Confluence knowledge or other bug tracking systems
Enthusiasm for evaluating new services and technologies
Experience with API's
Experience with Cloud environments (AWS)
BS degree in Computer Science or equivalent experience
Source: Job Diva – Job Listing
| Portfolio Analysts support targeted, effective and efficient business planning processes by sourcing, synthesising, summarising and providing key portfolio analytics that enable informed decisions to support ever-improving business results. Learn PRIME Project Management Tool and provide administrative maintenance, troubleshooting and 1st level user application support (locally) as well as 2nd and 3rd level user application support (globally across diagnostics division, DIA) to a team of project managers and functional users of a standardized, planning and budgeting tool.
This role will be primarily responsible for assisting the subject matter expert to develop accurate portfolio and resourcing dashboards and/or reports for Assay and Reagent Development (ARD) to inform the overall portfolio management and resourcing strategy, help identify gaps, and optimize the workforce. |
|||
| Responsibilities | |||
|---|---|---|---|
| Work under general supervision and guidance, provides PRIME Tool database support and inputs necessary for business processes involving the Roche Molecular Systems (RMS) Portfolio of R&D projects and initiatives (i.e. creating new projects in the tool, updating user templates, managing master data, users and access, etc. according to standardized processes). Support local Change Management processes related to project and template changes | |||
| Work under general supervision and guidance, provides PRIME Tool database support and inputs necessary for business processes involving the Roche Molecular Systems (RMS) Portfolio of R&D projects and initiatives (i.e. creating new projects in the tool, updating user templates, managing master data, users and access, etc. according to standardized processes). Support local Change Management processes related to project and template changes | |||
| Work under general supervision and guidance, provides PRIME Tool database support and inputs necessary for business processes involving the Roche Molecular Systems (RMS) Portfolio of R&D projects and initiatives (i.e. creating new projects in the tool, updating user templates, managing master data, users and access, etc. according to standardized processes). Support local Change Management processes related to project and template changes | |||
| Presents data and insights both verbally and in writing. Where applicable, involves external stakeholders supporting portfolio analytics and insights reporting | |||
| Provides insights on the project portfolio and proposals to improve the overall strategic plan | |||
| Updates departmental systems with current and accurate information | |||
| Plays a lead role in developing, recommending, implementing, and providing standardized and ad hoc portfolio tools in accordance with requirements, objectives and partner/stakeholder needs. Includes dashboard analytics and reporting | |||
| Solicits internal & external business partner/stakeholder input to ensure reporting will exceed stakeholder needs and objectives | |||
| Identifies, recommends and uses appropriate data sources for reporting | |||
| Works closely with cross-functional stakeholders to develop and implement appropriate metrics | |||
| Participates in the implementation of new or otherwise updated reporting, which may include contributing to the development and updating of training materials to assist stakeholders in the use and interpretation of such reports | |||
| Develop portfolio analysis and ARD progress and performance reports; including tableau reports and business presentations (budget dashboards, capacity analysis, and project and portfolio reports) | |||
| Builds and maintains effective professional working relationships with internal/external partners and stakeholders | |||
| Other duties as assigned by management. |
| QUALIFICATIONS |
| To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities. |
| Formal Training/Education | ||||
|---|---|---|---|---|
| Education Level | Education Details | Req | Pref | |
| Bachelor’s Degree | Bachelor’s degree in business, finance, life sciences, or equivalent combination of education and work-related experience. | X | ||
| Experience | ||||
|---|---|---|---|---|
| Years of Experience | Experience Details | Req | Pref | |
| 2-6 years | Experience in Data Analytics, Project Management and/or Finance preferably within an IVD or Healthcare setting, providing insightful analytics to drive decision making in complex business environments or Master’s Degree with focus on Data Analytics: MIS / Business Administration / Engineering / Other |
X | ||
| Are equivalencies acceptable? | |
|---|---|
| No | |
| Knowledge, Skills and Abilities | ||||
|---|---|---|---|---|
| Knowledge, Skill or Ability | Req | Pref | Proficiency | |
| Excellent time management and organization skills: can prioritise multiple tasks and goals to ensure timely and high-quality accomplishment of such | X | |||
| Strong analytical skills: ability to search, select, analyze and synthesize data and information from various domains | X | |||
| Strong financial acumen: proven financial methodologies, analysis, and reporting capabilities | X | |||
| Strong business acumen: in-depth knowledge of medical device/ biotechnology strategies and processes | X | |||
| Strong written and verbal communication skills: communicates in a concise and clear manner that supports expeditious and effective decision-making, ability to interact professionally with a diverse group | X | |||
| Strong project management skills | X | |||
| Proven ability to identify critical issues and potential solutions, sound track record of effective decision-making | X | |||
| Works well within teams and collaborates effectively | X | |||
| Travel Requirements |
|---|
None
Source: Job Diva – Job Listing
Description:
The Senior Manager/Manager serves as a QCFU resource for managing the compliance of CMOs (Cell banking, Bulk Drug Substance, Packaging/Labeling) and external testing labs to ensure product and associated data adheres to cGMPs, EMEA, ICH and JP regulations, and Company requirements.
This role participates in the resolution of CMO operational issues, maintains an effective working relationship with CMO’s and internal team members, tracks quality related issues, and participates in CMO business meetings as required.
This position works with DI+, PMU, and Exton CMC Program Management on a day-to-day basis to ensure review and approval of internal/external deviations and change controls, master and executed production batch records, test methods, release specifications, qualification/validation/stability protocols and reports, quality agreements, reference standard implementation, and BLA/IND/IMPD documentation.
This role is responsible for batch disposition and supporting external audit activities, where required.
This position works independently to ensure processes and products produced in the development and commercial phase within Company and adhere to international GMP requirements.
The decision-making scope of this position requires the person to determine suitability of product for further processing and eventual use in clinical and commercial product.
This position will support the creation and improvement of Quality Systems, while ensuring seamless and efficient efforts are applied to project activities.
This role ensures compliance with established policies and procedures.
Duties:
1.Assess suitability of cell banks, bulk drug substance, and packaged/labeled drug product for further processing and eventual use in clinical and commercial product
2.Ensure CMO compliance to international GMP regulations; as well as Company expectations, including trending and evaluation of issues for impact to product on a continual basis, as well as external audit support
3.Support review of technical protocols, reports, batch records and regulatory documentation(BLA/IND/IMPD) with emphasis on adherence to agreed upon quality systems and international regulations
4.Support review of deviations, OOS, and change controls affecting both internally and externally approved processes/products, including corrective action recommendations and approval of final actions
5.Develop, implement and maintain processes and procedures to support quality systems specific to the CMO interactions. Ensure processes and procedures are adhered to, consistent with GMPs and are value-added.
Required:
• B.S. in Science related field (or equivalent)•Minimum of 7 years of drug/biotech experience
• Minimum of 10 years of quality experience in a GLP, GMP and/or ICH/GCP environment
• Knowledge and experience with all aspects of Quality System Management, lot disposition, deviation and investigations, change management, complaints, CMC participation, training, preparing/reviewing Annual Product Reviews, and auditing
• Thorough working knowledge of regulated GMP systems as well as FDA, EMEA, ICH and JP regulations
• Ability to effectively communicate verbally and in writing
• Collaborative working style (internal and external) with supervisory experience
• Flexible in working with associates from all departments and organizational levels, including external partners, while meeting commitments
• Experience with requirements relating to the development of antibody-based bio therapeutics pharmaceutical development processes
• Problem-solving and decision-making skills, as well as the ability to prioritize and successfully manage complex and competing projects
• Ability to travel up to 25%
Source: Job Diva – Job Listing
Job Description
Update from Manager
Provide Validation/QC guidance in regards to clinical data programming tasks for multiple studies.
Provide Validation/QC support for study team members from the study start up to the end.
Review/Provide Validation QC support for the database, data transfer, SDTM mapping specs to ensure that documents and specification are consistent and comply with internal/industry standards.
Perform data reconciliation, data quality control, and program SAS edit checks..
Review/generate/validate electronic submission deliverables such as SDTM datasets,
Perform Quality Testing/User Acceptance Testing of EDC systems.
Support quality control and quality audit of deliverables.
Contribute to activities for validation/QC and implementation including standard reporting systems, SAS macro utility programs and associated tools.
Responsible for maintaining a formal quality control process in accordance with Clients standard operating procedures and Good Clinical Practice.
Perform validation & quality control to ensure all program development activities within the Oncology Business Group IODS follow established processes, and ensure proper documentation and timely posting into the TMF as required. This includes but not limited to the validation and QC support of clinical database design, reports & listings programs, SDTM conversion and related programming, post production changes, and implementation of programming tools within the IODS group
Essential Function
1. Work closely with the data management team members to coordinate and execute validation and QC activities
2. Evaluate system/study level validation/QC activities along with drafting of supporting documentation
3. Oversee testing and validation/QC activities of existing clinical studies
4. Collaborate with Regulatory and Publishing for submission activities
Job Qualifications
Bachelor or higher degree in Computer Science, Engineering or related field;
Minimum 5 years experience in the areas of software development life cycle supporting a GCP environment, clinical database set up in the pharmaceutical or related industries, clinical data management process and a practical understanding of GCP validation requirements
Aware of FDA, EMA, MHRA and ICH regulations and guidelines governing the conduct of clinical trails
Understanding of EDC systems, such as Medidata Rave, Inform, OC-RDC, IXRS (IRT), or other similar applications
Excellent oral and written communication skills; good people skills, good organizational skills to effectively guide multiple resources involved in various projects.
Excellent team player; able to work under pressure, handle situation involving different functions and teams
Source: Job Diva – Job Listing
Duties:
Interprets and evaluates test data in terms of accuracy and precision. Under the guidance of the manager conducts laboratory investigations and resolves technical problems.
Follows established company GDP procedures.
Contributes to milestones for specific projects.
Excellent oral and written communication skills.
Experienced in analytical instrumentation such as HPLC, GC, and UV/Vis Spectrophotometry
Education:
BS degree in Chemistry or related discipline with 3-5 years experience in a regulated laboratory setting.
Source: Job Diva – Job Listing
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