Are you ready to take a leadership role in maintaining stellar quality standards at a state-of-the-art facility?
We are seeking a Sr. Specialist of QA for QC to provide expert quality oversight, guidance, and critical decision-making for Quality Control (QC) equipment moves, qualifications, and decommissioning. Join a top-tier global biopharmaceutical leader and champion a culture of quality across our GxP and GMP laboratories.
location: Norwood, Massachusetts
job type: Contract
salary: $70 - 77 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Review and approve critical documentation for QC laboratory equipment, including validation protocols, reports, and method SOPs.
- Act as the Quality Lead to identify, review, and approve deviations, change controls, work orders, and CAPAs related to QC instrument activities.
- Empower laboratory staff by ensuring strict adherence to Good Documentation Practices (GDP) and Data Integrity requirements.
- Perform essential reviews of QC logbooks and execute operational quality tasks precisely as defined in internal SOPs.
- Support audit and inspection readiness by ensuring all equipment records are accurately maintained and readily available.
qualifications:
- Education: Bachelor's degree in Biology, Chemistry, Biochemistry, Engineering, or a related scientific field.
- Experience: 3-8 years of experience in CQV (Commissioning, Qualification, and Validation) within a GMP regulated biotech or pharmaceutical environment.
- Strong working knowledge of FDA, EU, and ICH guidelines.
- Hands-on experience managing deviations, change controls, and risk assessments.
- Technical proficiency in digital validation software (e.g., Kneat or equivalent).
skills: Good Manufacturing Practices (GMP), Quality Control (QC), Food and Drug Administration (FDA), International Council for Harmonization (ICH)
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.
