Elevate your career in biopharma quality compliance in Plainville, MA! A top-tier global life sciences leader is seeking a Quality Assurance Specialist for a 9-month onsite contract. Providing vital on-the-floor QA oversight, this position operates on a stable Day Shift Flex 12-hour rotating schedule and offers a premier environment for expanding your technical regulatory expertise.
location: Plainville, Massachusetts
job type: Contract
salary: $28 - 30 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Perform real-time, on-the-floor Quality Assurance oversight of GMP manufacturing operations.
- Review executed batch records and GMP documentation for accuracy, completeness, and strict regulatory compliance.
- Support site investigations, deviations, CAPAs, and change controls in partnership with senior QA staff.
- Escalate quality events, compliance risks, and atypical observations to management in a timely manner.
- Collaborate closely with Manufacturing, QC, and support functions to ensure absolute adherence to site SOPs and FDA/EU guidelines.
qualifications:
Required:
- Bachelor's degree in Life Sciences, Engineering, Microbiology, or a related field (equivalent training/experience considered).
- Minimum 1+ years of GMP industry-related experience.
- Working knowledge of FDA, EMA, and applicable GMP regulations and quality systems.
- Ability to gown fully and work comfortably within classified cleanroom manufacturing areas.
- Full availability for a Day Shift Flex 12 rotating schedule (6:45 AM-7:15 PM; Week 1: M/T/F/Sa; Week 2: Su/W/Th).
- Proficiency with electronic quality systems (eQMS) and advanced documentation review.
skills: Microbiology, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA)
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.
