Quality Control - Microbiology - Cell Cultures

Randstad USA; Norwood (MA); On-site; USD 56,000 - 58,000; Full time

Job summary

Randstad USA is seeking a Quality Control Associate II for our on-site biotech manufacturing facility in Norwood, MA. You will execute cGMP QC testing across raw materials, drug substances, and finished products, driving method transfers and ensuring compliance with standards to support patient safety.

The role requires hands-on experience with molecular biology, cell-based and potency assays, ELISA, and protein analysis, with a BA/BS and 3–5 years in cGMP labs.

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.

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

mammalian cell culture

cell based and potency assays

molecular biology

Education

BA/BS Degree

Bachelors

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 Degree

Experience: 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.

salary: $41 - $42 per hour

shift: First

work hours: 8 AM - 5 PM

education: Bachelors

Responsibilities

What you will be doing:

• 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 (1 year of experience is required)
• GMP (2 years of experience is required)
• raw materials
• Drug Substance
• ELISA (1 year of experience is required)
• mammalian cell culture (2 years of experience is required)
• cell based and potency assays
• molecular biology

Qualifications

• Years of experience: 2 years
• Experience level: Experienced

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 [e-mail].

Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offering, 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.

Experience

• Experienced
• 2 years

Education

• Bachelors