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Specialist, Quality Assurance, External DS
4 months ago
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. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you
location: Norwood, Massachusetts
job type: Contract
salary: $ per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug products produced internally. He/she will provide quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience in quality oversight or manufacturing experience in early stage clinical products. They will be able to interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Manufacturing, Logistical and Process Development Technology Transfer counterparts.
- Conduct thorough review of Master Batch Records (MBR) and electronic Batch Records (eBR), collaborating closely with the manufacturing team to ensure timely finalization of documentation.
- Perform quality inspections of logbooks that are pending review to ensure compliance and completeness.
- Provide quality supervision during the implementation of corrective actions and preventive actions (CAPA) and verify the effectiveness of these actions to sustain production continuity or advance processes to subsequent phases.
- Oversee the resolution of quality documentation, including deviations, change controls, CAPAs, Process Improvements (PI), and Engineering Changes (EC), prioritizing collaboration with interdisciplinary teams to expedite the completion of these records, addressing them in order of receipt or as per the backlog.
- Review and certify scanned copies of GMP documents submitted for archive.
- Additional duties as may be assigned as needed
qualifications:- 2-4 years of experience in a GMP Manufacturing environment
- Bachelor's degree in a science related field
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
skills: Quality Assurance, CAPA, 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
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).
Applications accepted on ongoing basis until filled.
