Provides lab support functions with staff under close supervision and in accordance with GLP/GMP. Performs some or all of the following in strict accordance with SOPs. Preparation of glassware (washing, drying, sterilizing). Operation of support equipment (autoclaves, glass washers, pH meters, balances). Maintaining stock inventories (chemicals, supplies, central stock room). Requires very few, if any of the requisite skills to perform the required tasks of the position at this level. Receives detailed instructions on all work. All activities are closely supervised and work is reviewed upon completion. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The work environment characteristics described here are representative of those an employee to encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This is a 6 month temporary position. The ideal candidate will perform all laboratory environmental monitoring loggin in entries as well as data entry, review, verification and data management activities in support of the Quality Department. The candidate should have a good working knowledge of Microsoft Office Word and Excel and be comfortable navigating within computer applications. Other laboratory duties will be assigned as needed, based on business demands. The ideal candidate must be detailed oriented, customer driven, and a team player. Candidate should have good hand writing and be very organized. Process troubleshooting- perform BPR comparison, data gathering, process observation.
Practical experience in general microbiology laboratory techniques working with bacteria, yeast and mold.
Preference will be given to candidates with prior experience in Sterility Testing, Isolators, Endotoxin Testing, and Identification Systems.
Excellent written and verbal communication skills.
Physical Requirements include the capacity to lift and carry up to 20 pounds, kneel, reach and stretch, and to stand for at least 4 hours
Job start time is 10:00 AM
Please see duties
Source: Job Diva – Job Listing
Description:
Recognized expert-level knowledge of relevant methodologies, technologies, languages, standards and processes with 8+ years of experience in relevant area, preferably with broad industry exposure. Capability to think strategically. Excellent understanding of complex landscapes and relationships (business, systems, policies, etc.). Excellent ability to communicate to others not only what is being done and how, but also why. Carrying out analytical activities and all software development tasks. Incorporating technical and operational requirements into IT solutions. Developing, researcheing, designing, implementing, testing, and evaluating various types of IT applications, programs, and software depending in domain.
Tasks & Responsibilities:
Implement database solutions/enhancements to support new and ongoing APEX applications
Iterative approach: deliver incremental features based on customer priorities in 3-4 sprints.
Close contact to the customers/users.
Standard documentation needed (ERM, Technical Description).
Creation of necessary concepts and scripts to migrate solution from pilot environment to production environment.
*This role is preferred to work on-site in SSF, however remote workers may be considered as long as they are available to work in PST (SSF) and CET (Basel) time zones.
Must Haves:
+5 years of experience as IT Specialist with similar tasks (implementation of database solutions)
Programming language skills: PL/SQL – Expert Level (+3 years hands on)
Databases experience: ORACLE – Expert (+3 years hands on)
Project experience: ORACLE APEX (must have at least one customer solution successfully delivered and rolled out using ORACLE APEX as a platform) *please note this is a REQUIREMENT
Nice to Haves:
Experience in User Interface Design (User Experience) – Use of APEX Themes
Workflows in APEX
Knowledge in JAVA, HTML, CSS
Source: Job Diva – Job Listing
As a member of the Data Analytics group, candidate will be responsible for supporting the Marketing and Field groups, delivering actionable insights through data analysis and reporting initiatives. This position will provide expertise in the analysis of all Client Oncology / Neurology brand & field information as well as manage Oncology / Neurology brand internal reporting operations. This position will be responsible for partnering with Client’s Oncology / Neurology Marketing teams to provide value added analytical insights critical to the success of Client’s business. Reporting functions will largely entail collaborating with Operations, IC, and Field Leadership to ensure all reports/ad-hocs meet business requirements. This position will also be responsible for managing contractors/consultants as part of the Commercial Analytics structure.
KEY RESPONSIBILITIES:
• Lead data analytics projects and inquiries for the Neurology & Oncology Groups
• Generate actionable information and insights which will enable better business decisions across Client
• Analyze Neurology and Oncology data, create / modify dashboards
• Maintain / consolidate and develop new reports/ad-hocs to monitor Neurology and Oncology business units
• Support key stakeholders with data consultation, gathering and analytics
• Work with various stakeholders to identify data mining needs and provide required data solutions / analysis / deliverables
• Maintain SOP documentation, gather and write and execute business requirements
• Lead Third Party Agreements and Vendor Management
• Coordinates with the Operations team to address the quarterly target change feedback received from the field teams
Job Qualifications – Knowledge/Skills/Abilities Required:
• Bachelor’s Degree (BS/BA) in an analytic discipline – engineering, mathematics, statistics, economics, etc. Master’s degree in a similar field or an MBA preferred
• 8 years Pharmaceutical industry knowledge (Sales Operations, Sales, Marketing)
• 4+ years Project/Vendor Management experience
• Excellent writing, training, and presentation skills, and demonstrated ability to influence others
• Strong Knowledge of third party pharmaceutical sales/script/call details data (DDD, NSP, Xponent, DataView, longitudinal patient data, claims data, etc.)
• Experience in working with IT staff as well as the ability to understand and guide technical work pertaining to data storage/organization, data access, etc.
• Strong programming (SAS / SQL), data analysis skills, plus curiosity, enthusiasm and commitment to growing these skills further
• MS Excel, PowerPoint and BI tools (MicroStrategy, Business Objects, etc.) -Intermediate to Advanced user
• Prior consulting experience a plus
• Finely tuned attention to detail
• Excellent organizational skills and the ability to balance multiple demands
• Excellent communication and interpersonal skills
• Proven and successful team player
• Self-starter with interest and ability to work both independently and highly collaboratively
• Excellent presentation skills
• Summarize, analyze, prepare, present various reports and findings in a clear/concise manner
Source: Job Diva – Job Listing
The Senior Specialist CTS QA works with global supply chain teams (US and UK) and CMO (contract manufacturing organizations) on a daily basis to review and approve master batch records, production batch records, change controls, labeling specifications, SOP, and other GMP documentation to release clinical trial material (CTM) for release. In addition, the individual will act as person-in-plant at CMO during primary production (eg, bottling or blistering) and secondary packaging (kitting) and labeling operations.
Essential Functions
1. Independent decision maker for assessing suitability of CTM for human clinical trials
2. Evaluate process set-up and operation for design to reduce likelihood of error and communicate and influence CMO in process set-up and operation
3. Approve pre-production records (eg, specifications, master production records, change controls)
4. Approve prost-production records (eg, production batch records, deviations, investigations, and change controls)
5. Disposition CTM in accordance with regulatory dossier filing
6. Evaluate existing Client processes for effectiveness and develop, revise, and maintain SOP to support CMO operations for primary and secondary packaging and labeling
7. Ensure CMO compliance to GMP and Client requirements and expectations; support audits as required
Requirements
• B.S. in Science field, or equivalent
• Minimum 3 years’ experience in drug primary and secondary packaging experience
• Thorough working knowledge and experience in all aspects of Quality System Management (lot disposition, deviations, investigations, training, and auditing)
• Ability to effectively communicate verbally and in writing
• Ability to work with associates for various departments and levels to meet delivery commitments
• Ability to travel locally up to 25%
• Person-in-Plant experience preferred
• Minimum 3 years’ experience in Quality auditing in GMP environment preferred
Source: Job Diva – Job Listing
Design experience :
Source: Job Diva – Job Listing
Design experience :
Source: Job Diva – Job Listing
Summary:
Client is seeking a Lab Technician to join the Quality Control team. This position is located within the Quality Control department and is responsible for providing support for QC testing and lab activities.
Primary responsibilities:
• Buffer / solution preparation
• Media preparation
• Lab stocking
• Lab ordering
• Waste Management (includes biohazard waste)
• Cleaning trap flasks
• Maintaining the lab in an inspection ready state
• Performing daily and periodic performance checks and calibrations on QC instrumentation.
Qualifications:
• Associate of Science (AS) or Associate of Arts (AA) Degree in science field
• Able to handle multiple tasks in an organized and time-efficient manner
• Well organized and able to manage own workload effectively
• Strong attention to detail
• Comfortable working in a team environment and interacting with other team members within the group
Source: Job Diva – Job Listing
Duties:
Assisting with scheduling of weekly and monthly maintenance of sterility test equipment
Performing sample decontamination prior to sterility testing
Coordinating the read off and documentation for sterility testing environmental monitoring
Management of sterility testing media (ordering, receiving, labeling, and stocking)
Assist with autoclaved media removal and GPQ testing evaluation
Ordering and stocking the sterility testing suite with consumable items
Performing logbook and controlled form monthly audits
Level I and Level II qualification for sterility testing
Qualification and Required Skills:
Bachelor degree in science, prefer micro or biology
Previous work in team environment
Someone not seeking "research” lab
Someone that can handle a little physical work
Flexible hours
Previous lab experience helpful, but not required for this position
Source: Job Diva – Job Listing
Molecular Biology Researcher
We are seeking an entry level molecular biologist who is going to assist our immunodementia drug discovery projects. The major responsibility of this position is to perform qPCR, western blotting, and flow cytometry for analyzing gene expression. A successful candidate will be able to work in a team-based setting, conduct experiments independently, and clearly communicate results with the team.
General DNA/RNA handling (required)
RNA extraction from cell culture and animal tissues (Required)
qPCR execution and data analysis (Required)
Western blotting (Required)
Cell culture techniques e.g. aseptic pipetting, cell passaging (Required)
Transfection of cultured cells (desired)
Flow cytometry (desired)
Transfection of cultured cells (desired)
Conduct experiments with consistency and accuracy
Enthusiasm, attention to detail, an ability to plan and organize work, and an interest in drug development
Requires: BS/MS in relevant scientific field
Source: Job Diva – Job Listing
Job Specification for Project Manager
Overview:
The primary role of the successful project manager candidate will be to support project managers/leaders engaged by client to facilitate the transition to a standardized project execution discipline.
The selected candidate will have 5+ years’ experience managing projects in the pharmaceutical or biopharmaceutical arena. Understanding of cGMP practices related to pharmaceutical supply chain: validation, equipment qualification, process development and validation.
The Biologics Manufacturing Continuous Improvement team is seeking an individual to manage projects that support continuous improvement, development and validation, and equipment qualification projects for implementation on the production floor.
Project Management Responsibilities include:
a. Initial Project Definition
1. Assist project leader in developing Project Plan (scope)
2. Interface with Project Leader to develop MS project schedule
b. Project Execution
1. Apply Project Management best practices to support the project leader for control and management of budget and resources, risk management, deliverables, and project decisions. Be able to communicate and influence personnel at all levels of the organization.
Source: Job Diva – Job Listing
Serve as an associate responsible for ensuring availability of data required for the generation of PSR reports, and ensuring the distribution and submission tracking activities for PSRs is performed. Actively contribute to the development and implementation of improved Client PV report processes as appropriate; oversee outsourced activities (eg QC, mentoring etc).
Duties:
Coordinate call of information based on MPT (Master Planning Table) extraction with GRA and any other relevant focal points across GPV. Ensure that the reports are run according to the proposed schedule; responsible for tracking when reports should be run so that we can plan resources appropriately.
Generate the monthly AWARE INN table based on the MPT to request validation and final line-listings needed for the completion of PSRs by Periodic Reports Associates (PRAs) and LPCs (Local Pharmacovigilance Contacts). The AWARE appendices package from SSU (Systems Support Unit) is extracted and prepared in accordance with internal procedure to meet regulatory requirements and avoid issues during the publishing process. Upload the final line-listings to DOMASYS for the preparation of PSRs.
Interface with GRA to ensure that the data needed for the regulatory sections of the PSR are received according to timelines guide.
Extract and format IMS for interval and cumulative sales data for PSRs and ad hoc.
Distribution of PSRs or other types of safety reports:
Ensures that all PSRs are distributed to the appropriate addressees in a timely manner.
Submission of PSUR to EMA. Prepare the submission package with relevant stakeholders and distribute to GRA for electronic submission. Monitor submission dates, liaise with GRA; complete the ATT (Affiliate Tracking Table) accordingly. Immediately alert hierarchy in case of high risk of non-compliance.
Skills:
Computer literacy especially in Windows based programs
Ability to effectively troubleshoot issues
Ability to prioritize and multitask
Excellent communication skills
Strong attention to detail and interpersonal skills within or outside department
Education:
BA or BS preferred
4 – 6 years of Pharma or related experience in document support/coordination activities
Understanding of technologies involved (specifically Advanced MSWord/MSExcel, and Acrobat)
Source: Job Diva – Job Listing
Responsible for the execution and analysis of experiments and analytical procedures. Displays an investigative or technological orientation in designing, executing and interpreting experiments and analytical procedures. Investigates basic technical problems and performs routine scientific procedures and experiments under general supervision. Plans and prioritizes concurrent experimental procedures. Integrates, complies, and tabulates data and assists supervisor in the analysis and interpretation of the results. May provide oral presentations on results to other department members. Works under active supervision. Follows established procedures. Work is reviewed for soundness of technical judgment and overall adequacy and accuracy. Contributes to the completion of milestones associated with specific projects. Failure to achieve results or erroneous execution may cause delays in program schedules, and may result in the allocation of additional resources. Frequent internal company contacts. Infrequent inter- departmental and outside constituent contacts on routine matters. Experience: 6+ years
The successful candidate should have good communication and presentation skills, possess a strong work ethic, and be motivated to excel in a team environment. Practical experimence with biochemical and biophysical characterization methods such as chromatography, electrophoresis, UV/CD/fluorescence spectroscopies, calorimetry, light scattering, and sedimentation is preferred.
Source: Job Diva – Job Listing
Performs laboratory analysis using current laboratory instrumentation such as TOC, pH, Conductivity, HPLC and GC
Analyzes chemical in-process materials, finished product and/or stability samples in support of the company's quality program. Interprets and evaluates the analyses in terms of accuracy and precision and recommends corrective action where necessary. Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devises and develops new analytical methods and techniques.
Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation (this includes pH meters, osmometers, viscometers, nephlometers, UV-spectrophotometers, HPLC, HPIC, GC, etc). Develop solutions to routine technical problems of limited scope. Work is closely supervised.
Follows specific, detailed instructions. Contributes to the completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Contacts are primarily with immediate supervisor, project leaders, and other professionals in the section or group.
Computer proficient. Previous laboratory skills are preferred, but not required
.
Source: Job Diva – Job Listing
Tasks
Create new pages based on standard template and as directed by Webmaster
Upload photos, documents, and videos
Copy and paste content from current website to new website
Track progress of the completion of page migration
Document and communicate any issues or questions to Webmaster
Provide design solutions and share with Webmaster as appropriate
Share experiences and input on content manager training materials- may be asked to assist in training content managers on web page maintenance
Attend team and content manager meetings as required.
Major Responsibilities
Create pages to host data from existing website with minimal supervision
Communicate to the Webmaster and developers with efficiency and accuracy on any progress and/or delays.
Participate in discussions with Webmaster and Content Managers on page migration strategy as required.
Requirements Detail oriented and able to work independently with minimal supervision.
Strong written and verbal communication skills
Experience with HTML, Hadoop, Pyspark, SQL and Oracle.
Source: Job Diva – Job Listing
Main purpose of the job:
• Understanding of the Regional Regulatory procedure for MAs and US post approval changes, extensions, and renewals.
• Provide support within the Global Labeling function in the US and UK, promoting and creating a professional environment
• Anticipate regulatory labelling obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Support operationalise labelling activities across all products
• Act as a support for local, regional and multi-country regulatory labelling requirements.
• Support the use and development of current and new tools, technologies and processes to support global label development, submission and approval in respective countries.
• Report to the Head of Global Labelling.
Main duties/responsibilities:
Responsibilities will include but not be limited to:
• Management of drug listing and establishment information in SPL by working effectively with vendors.
• Work with manufacturing/packaging sites concerning labeling changes and implementation, and respond to e-mail queries related to activities associated with assigned projects to ensure accurate daily workflow.
• Review/Approval of final artwork.
• Provide Supply Chain and QA guidance on labeling implementation requirements.
• Prepare summary of labeling changes (including components and revision/version information) during a given reporting period for inclusion in an Annual Report.
• Provide product labeling proofreading support, as necessary.
• Ensure product labeling reporting alignment with CFR and internal requirements.
• Maintenance of distribution lists, management of documents in an electronic document management system, compliance tracking and reporting, labeling systems management.
Tools and equipment used / working environment:
The Associate, Global Labelling is expected to possess a strong working knowledge of Microsoft Office applications, document management systems,
Working relationships:
The Associate will report to the Head of Global Labelling. This individual will be expected to routinely work in a global, multidisciplinary environment with such individuals as those within the Global Regulatory Network, the Oncology and Neuroscience Business Groups, Medicine Development Center, affiliates, partners, Legal, Commercial, and Safety.
1. Qualifications, education and language requirements:
• Bachelor’s degree or higher in Life Sciences
• Excellent written and spoken English
2. Experience Required:
• Experience in Regulatory, R&D or related area or equivalent experience within the pharmaceutical industry.
• Knowledge of global regulations, guidance documents, ICH guidelines, and demonstrated ability to apply regulatory guidelines to product labelling.
• Demonstrates a solid working knowledge of drug development
• Proven interpersonal skills; negotiating, communicating, coaching & explaining.
3. Skills and Aptitude Required:
• Experience in local and global regulatory environments and work on multiple projects.
• Be team oriented individual with personal commitment to human relations, integrity, giving and receiving constructive feedback, adaptability, diversity- working environment.
• Able to work under pressure.
• Scientific background or familiarity with medical terminology and knowledge of FDA regulations and guidance is preferred.
• Proficiency with document comparison software, Microsoft Office, Excel, Outlook, PowerPoint, SharePoint, and Adobe Professional.
• A high level of skill in written English, including spelling, grammar and punctuation.
• Experience with proofreading
• Detail oriented ability to work independently, and meet deadlines.
Source: Job Diva – Job Listing
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