QC Specialist – GMP Lab & ISO Compliance

Musculoskeletal Transplant Foundation; Valentine (NJ); On-site; USD 44,000 - 47,000; Full time

Benefits offered by this job

4 weeks Paid Time Off

Paid Holidays

Medical, Dental, Vision Insurance

401K plan with company match

Short & Long Term Disability

Life & Accidental Death Insurance

Tuition Reimbursement

Health Care/Dependent Care FSAs

Adoption Assistance

Voluntary Benefits

Job summary

Musculoskeletal Transplant Foundation (MTF Biologics) is seeking a QC Specialist to support multiple quality control functions, perform environmental sampling, and ensure regulatory compliance. You will report data, escalate discrepancies, and coordinate sample submissions with internal and external labs.

The role operates Monday–Friday, 8 AM–4 PM, in New Jersey. Responsibilities include testing across clean rooms and labs, reviewing data for out-of-spec results, and contributing to

Qualifications

• Bachelor's in Science or 3 years GMP/regulatory experience.
• 2 years QA/QC in GMP or FDA-regulated environment.
• Gowning/gloving qualification for ISO-classified areas.
• Proficient in data entry and Microsoft Office.
• Strong analytical and communication skills.

Responsibilities

• Perform QC tasks across clean rooms, laboratories, incoming material areas, QC sample rooms, and calibration systems.
• Analyze samples per approved OPs/WIs and ensure methods meet holdtime requirements.
• Reconcile samples and documentation in accordance with MTF documentation procedures.
• Collaborate with R&D, Supply Chain, internal laboratories, QE, and PE on lab studies and material inspection documentation.
• Perform environmental and chemical testing and troubleshoot equipment issues.

Skills

GMP/Regulated Industry experience

Data entry

Communication skills

Laboratory equipment operation

Gowning/gloving qualification for ISO

Education

Bachelor's in Science

3 years GMP/Regulated Industry related experience

Tools

LIMS

Job description

Musculoskeletal Transplant Foundation (MTF Biologics) is seeking a QC Specialist to support multiple quality control functions, perform environmental sampling, and ensure regulatory compliance. You will report data, escalate discrepancies, and coordinate sample submissions with internal and external labs.

The role operates Monday–Friday, 8 AM–4 PM, in New Jersey. Responsibilities include testing across clean rooms and labs, reviewing data for out-of-spec results, and contributing to