As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!
location: Cambridge, Massachusetts
job type: Contract
salary: $55.00 - 62.16 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Issue, review, and approve GMP documentation (e.g., batch records, SOPs, job aids, etc.) needed for internal manufacturing operations.
- Review logbooks and reconcile documentation.
- Assist with walkthroughs with senior Quality staff members.
- Review labeling and packaging batch records and prepare documentation for release.
- Review work orders, equipment qualification, and validation documentation for adequacy and compliance.
- Review batch record documentation, ensure compliance and accuracy, and prepare for drug substance/product and/or critical material release.
- Engage in daily onsite quality oversight and guidance and collaborate across functions, leveraging quality and manufacturing expertise to provide guidance on non-conformance/deviations, troubleshoot/problem solve, interpret data, and apply a risk-based approach for ongoing manufacturing operations and related quality events.
- Represent QA in onsite operations from the thaw of starting material to drug substance/product filling and labeling.
- Additional duties as assigned.
qualifications:
Required
- Bachelor's Degree in Biology, Microbiology, Chemistry or related field
- 4+ years of experience in cGMP Quality Assurance in Biologics or Cell & Gene Therapy product manufacturing
- Master's Degree in Microbiology, Biology, Chemistry or a related field
- Working knowledge of cell or gene therapy product testing, manufacturing, or development
- Demonstrated knowledge of current GMP regulations associated with pharmaceuticals, cell therapies, gene therapies, etc. in the field of responsibility.
- Understanding and working knowledge of Quality Management System expectations, ability to interpret requirements, anticipate issues, make informed decisions, and respond rapidly to emerging quality situations. in the field of responsibility.
- Local travel between manufacturing sites required.
skills: SOP, Quality Assurance, GMP (Good Manufacturing Practice), Manufacturing Operations
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.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
