Drive quality excellence in a cutting-edge biotechnology facility! A Top-Tier Global Pharma Leader in Norwood, MA is seeking a Sr. Specialist of QA for QC to provide critical quality oversight for lab equipment relocations, qualifications, and decommissioning across site laboratories. Ensure high-standard GxP compliance and elevate data integrity in a fast-paced environment.
location: Norwood, Massachusetts
job type: Contract
salary: $70 - 77 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Review and approve qualification/validation protocols, reports, logbooks, and method SOPs to guarantee lab equipment readiness and cGMP compliance.
- Enforce Good Documentation Practices (GDP) and Data Integrity standards across all Quality Control personnel activities.
- Manage, review, and approve deviations, change controls, CAPAs, and work orders related to QC instrument management.
- Provide risk-based quality decisions to maintain full alignment with internal procedures and FDA/EU regulations.
- Execute compliance and validation tasks precisely as specified in standard operating procedures and internal guiding documents.
qualifications:
Required:
- Bachelor's degree in Biology, Chemistry, Biochemistry, Microbiology, Engineering, or a related scientific discipline.
- 3-8 years of CQV experience in a biotech/biopharmaceutical cGMP environment, preferably within Quality Assurance or Quality Control.
- Strong working knowledge of FDA, EU, and ICH regulations and cGMP guidelines.
- Direct experience with deviation management, change control, risk management, and digital quality systems.
- Proficiency with Microsoft Office tools and statistical software.
- Familiarity with Kneat software or equivalent qualification platforms.
- Hands-on experience with analytical or microbiological testing, method validation, and method transfer.
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.
