Pharmaceutical Quality Control Associate
Job Description
Ready to Make an Impact in Biotech Quality Control?
Join a high-performing team dedicated to advancing life-saving therapies! We are seeking a detail-oriented Quality Control Associate II to support cGMP QC testing for raw materials, drug substances, and finished products at our state-of-the-art manufacturing facility.
In this hands-on, on-site role, you will execute and troubleshoot core analytical methods, drive method transfers, and ensure absolute compliance with cGMP standards. If you excel in a fast-paced environment and want to apply your testing expertise directly to patient safety, this opportunity is for you!
The Role The Quality Control Associate II will support cGMP QC testing for raw materials, drug substances, and finished products at the company's manufacturing facility and affiliated contract organizations. This role includes executing and troubleshooting analytical methods, supporting method transfers, qualification activities, and ensuring compliance with cGMP standards. This is an on-site position.Here’s What You’ll Need (Basic Qualifications) Education: BA/BS DegreeExperience: STEM degree with 3-5 years’ of experience in a cGMP laboratory setting, with hands-on experience in mammalian cell culture, cell based and potency assays, ELISA, molecular biology, and Protein Analysis.Here’s What You’ll Bring to the Table (Preferred Qualifications)- Method development/qualification experience with molecular biology, cell-based assays, or protein analysis methods.
- Trained in Aseptic techniques and general laboratory instrumentation (e.g. pH meters, balances, pipettes)
- Ability to prepare reagents, pipette small volumes, work in a Biological Safety Cabinet
- Experience with laboratory equipment calibration and maintenance.
- Ability to work effectively in a fast-paced, cross-functional matrix environment.
- Familiarity with relevant FDA, EU, ICH guidelines, and regulations.
shift: First
work hours: 8 AM - 5 PM
education: Bachelors
Responsibilities
- Execute QC molecular biology and Bioassay methods (e.g. Mammalian cell based potency, qPCR, sequencing, protein analysis)
- Assist in troubleshooting equipment and assay issues.
- Perform general laboratory support activities including reagent preparation, equipment maintenance, housekeeping, logbook reviews, etc.
- Establish and maintain a safe laboratory working environment.
- Write, revise, and maintain SOPs, protocols, and reports.
- Support training as assigned.
- Assist in execution of Quality records (i.e. investigations, change controls, CAPAs)
- Ensure compliance with cGMP documentation and regulatory guidelines.
- Accountable for all mandatory training and assigned tasks.
- Provide support during audits and collaborate on continuous improvement initiatives.
- Additional duties may be assigned.
Skills
- Quality Control
- Quality Assurance
- cGMP
- GMP
- raw materials
- Drug Substance
- ELISA (1 year of experience is required)
- mammalian cell culture
- cell based and potency assays
- molecular biology
- Years of experience: 2 years
- Experience level: Experienced
Qualifications
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.
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 [email protected].
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.
