Coordinate activities relating to the qualification, calibration and maintenance of computerized laboratory equipment and related systems.
o Establish and maintain Equipment History Files (EHF) for QC laboratory equipment. Routinely assumes leadership role for instrument qualification.
o Demonstrate an understanding of CGMP's and 21 CFR compliance and how it applies to laboratory instruments
o Schedule/plan/execute computer validation activities of computerized laboratory equipment.
o Monitor and ensure ongoing compliance of all laboratory equipment and associated systems.
o Develops and authors complex and explicit documentation to support instrument qualification and software validation.
o Author protocols and technical reports related to the implementation of QC equipment
o Authors GXP Criticality and ERES assessments.
o Work independently with minimal supervision and direction.
o Practice safe work habits and adhere to client's safety procedures and guidelines Exercise sound judgment and decision making when problem-solving
Basic Qualifications
Bachelor's Degree in Chemistry, Life Sciences, or IT discipline and 3 years of Industry relevant experience Or Master's Degree in Chemistry, Life Sciences, or IT discipline and 1 years of Industry relevant experience
Minimum of 1 year of experience related to instrument software validation in a regulated environment such as GMP.
Preferred Qualifications
Demonstrated scientific technical writing ability. Knowledge of USP 1058 and GAMP methodology. Knowledge of 21CFR Parts 11,210,211,600 and 610. Previous hands-on experience performing laboratory equipment qualification, including software validation. Proficient in Outlook and Microsoft Office and lab-based data management systems.
Proficient in MS Office and Lab-based data management systems
Ability to present technical data
Ability to work independently on scientific projects
Familiarity with USP and global compendial regulations
Scientific technical writing ability including authoring and revising SOP's or technical reports
Special Working Conditions
Must be able to lift 40lbs
Must be able to gown for entry into the QC lab area
Must be able to work on a flexible schedule on a periodic basis based on business need
Source: Job Diva – Job Listing
Position Summary
Quality Control Validation Scientist I is responsible for the qualification activities, following SOPs and regulations including Data Integrity, related to one or more of the following areas: IQ, OQ, PQ and requalification.
Core Responsibilities
• Perform qualification in a cGMP biotech facility managing multiple complex qualification projects and providing technical assistance to less experienced team members.
• Write, review and approve qualification protocols and reports as well as execute protocol. Resolve protocol discrepancies and deviations.
• Evaluates new technologies platforms for implementation in the QC Laboratories.
• Ensure GMP compliance of all activities performed.
• Represent QC Validation in internal and external audits as required.
• Ensure appropriate facility support and provide technical expertise with regards to equipment.
• Review standard operating procedures.
• Maintain positive relationship and network effectively across sites and organizations.
• Provide project oversight and participate in cross-functional teams.
• Practice safe work habits and adhere to Company’s safety procedures and guidelines. An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
• Perform other additional job related duties as required.
• Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our Company policies and procedures.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Company a great place to work, and a company respected for the quality of its people and products.
• Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
Skills
• Knowledge of Validation Lifecycle Approach.
• Knowledge of Validation Data Integrity Principals
• Ability to present technical data.
• Ability to work independently on scientific projects.
• Scientific technical writing ability authoring and reviewing SOPs, qualification protocols and technical reports.
• Experience troubleshooting of assay and equipment issues
Education
• Bachelor’s degree in Life Sciences discipline and 5 years of experience in cGMP lab environment, or
• Master’s degree in Life Sciences discipline and 3 years’ experience in cGMP lab environment.
• PhD in Life Sciences discipline and 0-3 years’ experience in cGMP lab environment
Source: Job Diva – Job Listing
Job Specific Duties:
________________________________________
Perform formulation screening, prepare and characterize dosing formulations for animal studies. Conduct HPLC method development and samples analysis of small molecules in support of discovery formulation development. Measure protein concentration of monoclonal antibodies to support biotherapeutic programs. Troubleshoot analytical instrumentation and solve technical problems. Independently conduct formulation research and process improvement as needed. Interpret results and write technical reports. Responsible for general laboratory maintenance, buffer preparations, labeling, packaging and shipping of outgoing materials.
Skills:
HPLC, SEC, UV and LC/MS
Microscopy
Particle size analysis
Experience with solubility, stability studies and formulation screening.
Ability to multi-task and work efficiently in a fast paced and dynamic environment.
Ability to manage multiple projects while maintaining efficiency and effectiveness.
Ability to independently design experiments and conduct formulation research.
Excellent organizational and communication skills.
Ability to work independently and in a team environment.
Education:
MS (with 0-5 years related experience) in pharmaceutical sciences or analytical chemistry.
General Duties:
Responsible for the execution and analysis of experiments and analytical procedures. Display an investigative or technological orientation in designing, executing and interpreting experiments and analytical procedures. Investigate basic technical problems and performs routine scientific procedures and experiments under general supervision. Plan and prioritize concurrent experimental procedures. Integrate, compile, and tabulate data and assist supervisor in the analysis and interpretation of the results. May provide oral presentations on results to other department members. Contribute to the completion of milestones associated with specific projects. Frequent internal company contacts. Infrequent inter- departmental and outside constituent contacts on routine matters.
Source: Job Diva – Job Listing
Summary:
Perform audits necessary to ensure the compliance of manufacturing procedures to in-house specifications and government regulation.
Establish auditing requirements, quality standards and test methods in accordance with regulations and relevant quality requirements.
Conduct internal audits of manufacturing processes to ensure compliance.
Conduct review of testing results. Review document and complete inspection of returned goods.
May be involved with establishing compliance requirements for the methodology transfer from Research to Quality Control.
Interpret complex, explicit documentation to ensure quality standards and compliance.
May provide training to new employees.
Work under only very general supervision.
Work is reviewed for soundness of judgment and overall adequacy and accuracy.
Contribute to the completion of organizational projects and goals.
Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify.
Frequent internal company and external contacts.
Represent organization on specific projects.
Experience: 6 – 9 Years
Source: Job Diva – Job Listing
The IT Business Systems Analyst will be responsible for working closely with partners from Manufacturing (PT) Supply Chain Warehouse and the PT IT group in order to implement a pilot of a cloud-based, end-to-end temperature monitoring solution for clinical drug shipments.
Duties:
Support the design and implementation of a pilot system that is cost effective and meets user requirements through subject matter research, interviewing stakeholders and conducting workshops.
Analyze/document business scenarios and identify opportunities for improvement through automation and/or business process change.
Create and manage business analysis lifecycle documents such as functional requirements/specifications, report requirements/specifications and integration requirements/specifications.
Support end user feedback on the solution design, as needed.
Adjudicate the solutions adherence to requirements during testing and defect triage.
Proven knowledge of pharmaceutical supply chain/warehouse logistics.
Demonstrated excellence in analysis, documentation, facilitation and presentation skills.
Strong skills in leadership, critical thinking, structuring, communication across a wide range of management levels and facilitation of small and large groups.
Experience and knowledge of processes and procedures for GxP validated systems.
Experience with global / multi-site deployment projects
Excellent communication skills
Fluent in English (written and spoken)
Cloud computing solutions and/or IoT device experience is a plus.
Source: Job Diva – Job Listing
Source: Job Diva – Job Listing
Perform operations necessary for quality testing and plays a role in implementing new technology within quality control. At more senior levels, provide an investigative or technological orientation in designing, executing, interpreting and validating quality procedures and test methods. Complete routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation. Aid in the development of test methods. Conduct data review and preliminary evaluation of results. Solve problems using limited predetermined options such as repeating the assay when parameters are not met to determine the cause, etc. Provide input to the technical composition of operating documentation. Work is closely supervised. Follows standard practices to obtain solutions. Contribute 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 and other personnel in the section or group.. Years of Experience: 3 – 6 Years
Source: Job Diva – Job Listing
Track and review change control documentation. Assist with the editing of quality documents (Master Batch Records, SOPs, guidelines, etc.) to ensure compliance with regulator and internal quality requirements. Must be able to work quickly with a high degree of accuracy. Must possess sound interpersonal and information gathering skills, be able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others. Prepare and/or maintain documentation pertaining to programming, systems operation, and user documentation. Translate business specifications into user documentation. Plan, write, and maintain systems and user support documentation efforts; including online help screens. Knowledgeable of commonly used concepts, practices, and procedures within a particular field. Rely on instructions and pre-established guidelines to perform the functions of the job.. Years of Experience: 0 – 3 Years
Source: Job Diva – Job Listing
Clinical Systems Associate
Job Purpose
The Clinical Systems Associate (CSA) provides the ongoing day-to-day maintenance of the clinical systems that support the business needs of the Clinical Operations. A successful CSA assists with the development, documentation and communication of UAT processes and procedures. The key deliverable for this role is to ensure timely, quality conduct of clinical systems according to protocols, standard operating procedures and all applicable regulations governing the conduct of clinical trials.
Primary Responsibilities & Accountabilities
Experience, Skills, Knowledge
Education/Qualifications
Source: Job Diva – Job Listing
Track and review documentation. Assist with the editing of quality documents (SOPs, guidelines, validation master plans, etc.) to ensure compliance with regulator requirements. Must be able to work quickly with a high degree of accuracy. Must possess sound interpersonal and information gathering skills, be able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others. Prepare and/or maintain documentation pertaining to programming, systems operation, and user documentation. Translate business specifications into user documentation. Plan, write, and maintain systems and user support documentation efforts; including online help screens. Knowledgeable of commonly used concepts, practices, and procedures within a particular field. Rely on instructions and pre-established guidelines to perform the functions of the job.. Years of Experience: 0 – 3 Years
Source: Job Diva – Job Listing
Summary:
You will support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at the Company industrial sites. The mission is to deliver robust and efficient process & testing with associated know-how transfer to Manufacturing & Quality Control (QC).
• Develops and manages all single use and multi-use system process designs associated with the specific projects. This includes but is not limited to:
o Develop details required for product process system Basis of Design (URS's, Process Flow Diagrams (PFDs) and Process Descriptions)
o Responsible for the design of single use systems and/or select multi-use systems based on product process requirements (interface with product process owners)
o Assist in execution of functional testing (C&Q of fixed and single use), including the review/approval of test plans, data packs and reports
o Support project teams in their selection of single use and multi-use systems, including supplier capabilities, shop drawing reviews, etc.
• Responsible for process design and continuous improvements, including:
o URSs, Design of Single Use Systems, Process Flow Diagrams, Process Narratives
o Identifying multi-use equipment
• Author and approved protocol and reports supporting execution of functional testing
• Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines.
• Input to design space / DOE studies through establishment of scale-up / scale-down parameters utilizing engineering fundamentals (mixing, mass / heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.
• Partner with Engineering to ensure industrial implementation of process design, including review of engineering design documents, provide review and input to C&Q strategy and participating in testing of equipment
• Provide technical assistance to manufacturing technology for process troubleshooting.
Education and Experience:
Basic Qualifications: (Must be measurable)
• BS in Engineering (chemical, biochemical, mechanical or similar) with a minimum of 7 years industrial experience.
Preferred Skills:
• Expertise in process equipment design and implementation, including disposables
• Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control.
• Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
• Experience in equipment start-up, qualification is preferred.
• Proficient in MS Office 365 software
• Proficient in communication tools- Outlook and Zoom
• Proficient in a cGMP documentation system preferably GEODE.
Source: Job Diva – Job Listing
POSITION SUMMARY:
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.
ESSENTIAL FUNCTIONS: – Executes laboratory experiments; makes detailed observations and analyzes data. – Prepares technical reports, summaries and quantitative analyses. – Maintains complete and accurate records. – Normally receives detailed directions on all work. – Makes suggestions to improve work processes. – Assists in reducing to practice patentable inventions. – Works on projects of moderate scope in which analysis of situation or data requires a review of identifiable factors. – Exercises judgment within defined procedures and practices to determine appropriate action. – May participate in cross functional technical team activities. – Presents and discusses data within group. – Monitors work to ensure quality, and continuously promote Quality First Time.
Knowledge, Skills and Abilities: – Knows basic and some specialized laboratory techniques. – Familiar with searching scientific literature. – Skilled with use of word processing, spreadsheets, graphical and presentation software applications.
Source: Job Diva – Job Listing
Summary:
Under the supervision and guidance of a manager, apply clinical/medical background to review medical conditions; identify clinically important information from safety report that needs to be recorded by the site in the clinical database; review patient records to identify discrepancies, inconsistencies, or missing data; review AE, SAE cases as directed. Advise a better code using a standard medical dictionary (MedDRA, WHODD). Perform review of protocol and CRF in relation to coding and evaluation of safety data.
Performs all duties according to company policy and regulations and guidance.
Performs other duties assigned. No travel required.
Quantitative analysis – Generate clinical queries on subjects that met the criteria to have a narrative. Generate clear and brief narratives in accordance to the minimum requirement for regulatory submission. May assists in review of the reported and coded terms.
Qualitative analysis – Provides a clinically meaningful narratives (patient summaries) while following the writing guidelines. Evaluates the narrative index table if this met the minimum requirement for the narrative in preparation to the generation of narratives for inclusion in the regulatory submission.
Required:
Medical Degree, Physician-Assistant or PharmD or graduate of adequate health care related course with commensurate experience in use of dictionaries in Clinical trial setting. 5 plus years' experience.
– Educational background in medical field with strong understanding of pathophysiology of diseases.
-Performed medical assessment/ medical data review for at least 2 years
– knowledge of medical terminology, ability to apply to clinical coding using standard medical dictionary
– Knowledge of Central coding a plus, if not will train
– Experience with INFORM is a plus, otherwise ability to use/learn complex computer system
– Knowledge of Oncology Clinical trial Study is a plus, or ability to learn and apply experience in the area of clinical research
– Computer proficiency and Expertise on use of Excel and Word
– Strong oral and written communication skills
– Self-motivated, pro-active, and quick learner
Source: Job Diva – Job Listing
Summary:
The system administrator takes responsibility for the day to day administration of one or more Quality Management System Applications. Support the operational life cycle of electronic systems and system users. Provide front line to support for users, answering questions, providing training, investigating and resolving issues, and tracking issues to resolution. Maintain system in a validated state.
Responsibilities:
System support and administration of on-premises and hosted software solutions
Support user requests to modify the system within its validated state by performing admin tasks while maintaining system security
Investigate issues user issues, perform troubleshooting, and track to resolution. Trend issues to proactively implement changes to prevent future recurrence
Assist with managing changes to supported systems
Author service level agreements and ensure software solutions meet service level agreements with internal and external end users
Ensure software solutions, documentation and SOPs are inspection ready
Assist with creating system validation documents including authoring technical requirements, report specifications and with validation testing
Contribute to project milestones
Write/revise, collaborate on, and approve program procedures; ensure documents reflect current practices
Provide support during audits and inspections
Represent group on cross-functional or external teams.
Own simple continuous improvement activities
Perform training for supported systems
Independently determines and develops approach to solutions for day-to-day. May determine methods and procedures on new assignments
Qualifications:
2+ years experience in GMP regulated industry.
BS or 5+ years relevant experience
Familiarity with systems integration security, user provisioning, and single sign-on technologies.
Self-disciplined with strong initiative and the ability to learn quickly and apply new skills efficiently.
Strong organizational, problem-solving, and analytical skills.
Excellent written, email and verbal communication skills.
Commitment to excellence and high standards in relations to customer service.
Source: Job Diva – Job Listing
looking for an ITOC specialists to provide first level support in a 24×7 environment. Candidate will be responsible for providing 1st tier/level support to internal and external end users by answering calls and resolving trouble tickets (20 tickets on average) of varying complexity. Typical issues will be troubleshooting internal system access, password resets, and windows applications. The ideal candidate will have steady job history (not job hopping) be a team player, possess excellent customer service skills, and will need to hit the ground running to provide support quickly. This is a fast paced environment so candidates who can catch on quickly and essentially be a 'jack of all trades' with regards to handling issues, would be great. Candidate will have 2-3 years of technical support experience ideally in a 24×7 environment and it would be great if they have previous experience in a Network Operations center.
ESSENTIAL JOB FUNCTIONS
– Provide first level telephone support for end-user applications. (windows support, application troubleshooting, password resets, etc…)
– Process system access requests, password resets and conference bridge setups.
– Diagnose, resolve or escalate issues and problems.
– Assist System Administrators and Business Process owners in production related issues.
– Monitor and support internal systems, create service tickets (estimated around 20 tickets, but that depends on complexity), and call out of administration support staff to resolve issues.
– Report on system and application issues and metrics as deemed appropriate.
– 911 enhanced support.
– Compliance with all processes, procedures, and standards applicable to the position including (but not limited to): SAS 70 (Statement on Auditing Standards 70), CIP (Critical Infrastructure Protection), Change Management, Tariff (Open Access Transmission, Energy and Operating Reserve Markets Tariff), FERC (Federal Energy Regulatory Commission), NERC (North American Electric Reliability Corporation), U.S. Department of Homeland Security, and NAESB (North American Energy Standards Board).
Preferred Experience:
Plus:
– Knowledge /Experience with Solarwinds or monitoring
– Experience with enterprise monitoring background (NOC), application monitoring and or leaning towards more of TIER2 support. (This is not mandatory, but we will be more selective during the interview process.)
– Bachelors/Associate Degree in an IT related field
– Application monitoring experience is a plus for the candidate, but not a deal breaker.
Shifts:
Source: Job Diva – Job Listing
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