Quality Control Specialist

Musculoskeletal Transplant Foundation • Edison, NJ

1d

About The Position

The Quality Control Specialist supports multiple quality control functions to ensure compliance with established quality standards and regulatory requirements. The role performs environmental sampling and testing, documents results, identifies atypical or out-of-specification conditions, and escalates concerns to management. The specialist also performs titration testing, inspects critical and incoming supplies, prepares documentation for supervisory review, and maintains accurate, complete, and compliant electronic and paper records.

The position coordinates routine sample submissions with internal and external laboratories, including packaging and shipping, and escalates complex discrepancies. It supports QC activities across clean rooms, laboratories, incoming material areas, QC sample rooms, and calibration systems, and collaborates with R&D, Supply Chain, internal laboratories, Quality Engineering, and Process Engineering. The role also supports investigations and corrective actions, reviews documentation used for environmental monitoring release criteria, enters information into LIMS and external laboratory portals, and uploads calibration data into Blue Mountain.

Schedule: Monday through Friday, 8:00 a.m.–4:00 p.m. Pay range: $32–$34 per hour.

Requirements

• Bachelor’s degree in a science field, or three years of GMP/regulatory industry-related experience, or an equivalent combination of education and work experience.
• Two years of Quality Assurance or Quality Control experience in a GMP or FDA-regulated industry.
• Maintain qualification under the gowning/gloving procedure for entry into ISO-classified areas.
• Demonstrated good laboratory practices and ability to interpret laboratory data.
• Ability to operate laboratory equipment and software systems.
• Ability to recognize and escalate atypical results, equipment issues, or documentation discrepancies.
• Effective written and verbal communication skills.
• Proficiency in data entry and Microsoft Outlook, Word, and Excel.

Responsibilities

• Perform Quality Control tasks across clean rooms, laboratories, incoming material areas, QC sample rooms, and calibration systems.
• Analyze samples according to approved OPs/WIs and ensure methods meet hold-time requirements.
• Reconcile samples and documentation in accordance with MTF documentation procedures.
• Collaborate with R&D, Supply Chain, internal laboratories, Quality Engineering, and Process Engineering on laboratory studies, sample management, and incoming raw material inspection documentation.
• Perform environmental and chemical testing, including collection of environmental samples.
• Troubleshoot equipment issues to maintain proper operation.
• Maintain gowning and gloving qualification for ISO-classified environments.
• Escalate out-of-specification environmental results and other atypical conditions, equipment issues, or documentation discrepancies.
• Understand ISO requirements for cleanroom classifications and identify out-of-specification conditions during testing.
• Evaluate data and accurately review laboratory, quality control, and calibration data for out-of-specification results.
• Provide data, documentation, and observations to support investigations and corrective actions led by QC Management or Quality Engineering.
• Support the supervisor in reviewing and approving incoming materials used in processing, laboratories, and finished goods.
• Conduct measurements, record data accurately, and verify materials meet specified requirements before approval.
• Coordinate sample packaging and shipping, and communicate with external laboratories to resolve sample submission discrepancies.
• Review cleaning documentation, autoclave logs, chemical make-up logs, and other documentation used for environmental monitoring release criteria; escalate concerns to management.
• Upload calibration data into Blue Mountain and escalate calibration discrepancies to equipment owners and designees.
• Enter data accurately into LIMS and external laboratory portals.
• Provide input on updates to OPs, WIs, and forms.
• Perform additional duties as assigned.

Benefits

• Four weeks of paid time off (PTO).
• Paid holidays.
• Medical, dental, vision, and prescription drug insurance.
• 401(k) plan with company match.
• Short- and long-term disability insurance.
• Life and accidental death insurance.
• Tuition reimbursement.
• Health care and dependent care flexible spending accounts.
• Adoption assistance.
• Voluntary benefits, including pet insurance, legal insurance, and home and auto insurance.
• Sword Health at-home physical therapy.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level