Dive into the heart of cutting-edge mRNA production! We're looking for a sharp QA Specialist to take charge directly on the plant floor-ensuring smooth batch execution, keeping operations fully compliant, and driving rapid quality decisions in real time.
location: Norwood, Massachusetts
job type: Contract
salary: $45.00 - 54.86 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Provide real-time QA oversight on the manufacturing floor, conducting regular walkthroughs and real-time process observations.
- Review and approve electronic and paper batch production records to ensure strict cGMP compliance.
- Support deviation management, root-cause investigations, and corrective action execution.
- Perform alarm acknowledgments, equipment monitoring, and cleanroom behavior oversight.
- Partner with cross-functional teams on raw material release, plasmid/drug substance disposition, and SOP reviews.
- Maintain strict adherence to data integrity standards and site quality guidelines.
qualifications:
Required:
- Bachelor's Degree or equivalent years of experience
- Experience: 2-5 years of GMP experience in QA, training or document control experience in the biotechnology/biopharmaceutical industry, or other regulated industry.
- Knowledge of FDA, EU, ICH guidelines, and relevant regulations.
- Experience with quality systems, including batch record review, deviation management, and change control.
- Proficiency in authoring and reviewing GMP documentation.
- Familiarity with environmental monitoring and microbiological testing.
skills: SOP Development, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Deviation Investigation, Quality Assurance (QA), Raw Materials
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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (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.
