Quality Control Analyst
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location: Lexington, Massachusetts
job type: Contract
salary: $50.00 - 53.88 per hour
work hours: 9 to 5
- Project Management of Stability Studies for Drug Products, Drug Substances and Intermediates as well as associated Data Evaluations and Documentation
- Assignment and continuous Monitoring of product shelf life
- Authoring of technical documents for regulatory submissions
- Management of stability studies for assigned products
- Generation of stability protocols and stability reports (e.g. final reports, PQRs, annual reports)
- Authoring and review of stability sections for regulatory submissions
- Writing and review of responses for health authority requests and communication with regional authorities
- Statistical analysis and evaluation of stability data (e.g. Shelf Life or Internal Alert Limit determination)
- Subject matter expert for stability during audits and inspections
- Stability OOS/OOT investigation ownership
- Evaluation of transport temperature excursions
- Performing change request assessments with regard to stability
- Generation and review of SOPs and forms for processes associated with stability study management
- Implementation of Global Standards and Processes for Stability Study Management
- Implementation of Continuous Improvement Projects within the Department
- Coordination and Management of stability activities at external contract organizations (CMO, CTL, CRO) including procurement activities
- Other Responsibilities and Projects as assigned.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Experienced in GMP regulations and compliance requirements
- Knowledge and understanding of ICH and other regulatory requirements.
- Knowledge and ability to author stability CMC sections and regulatory responses
- Experience with various quality systems (e.g. investigations, CAPAs and change controls)
- Fluent in English (written and oral)
- Good GDP skills
- Technical writing skills.
- Conducts work in compliance with cGMPs, safety and regulatory requirements
- Relevant experience with pharmaceutical pipeline products and CMC aspects of regulatory filings.
- Scientific knowledge in protein / plasma / antibody chemistry / small molecule products
- Good analytical and problem solving abilities
- Experienced in working with global teams
- Typically requires Bachelor/ Master Degree in Science or Engineering or several years of Experience in pharmaceutical Industry Science related degree is preferred
- Team Player
- Good Communication Skills
- Seeks and considers feedback
- Global Cultural Awareness
- Ability to prioritize work and multitask.
- Limited to no travel expected. Travel between sites may be required.
skills: GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.