Quality Control Specialist

MTF Biologics • Edison, NJ

3d • $32 - $34

About The Position

The Quality Control (QC) Specialist supports multiple quality control functions to ensure compliance with established quality standards and regulatory requirements. The role performs environmental sampling and documents results, reports atypical conditions to management, performs titration testing, inspects critical supplies, prepares documentation for supervisory approval, and organizes electronic and paper logs to maintain data accuracy, completeness, and compliance. The QC Specialist coordinates routine sample submissions with internal and external laboratories and escalates complex discrepancies to management.

The position performs QC work across clean rooms, laboratories, incoming material areas, QC sample rooms, and calibration systems. It analyzes samples according to approved OPs/WIs and applicable hold-time requirements, reconciles samples and documentation under MTF procedures, conducts environmental and chemical testing, troubleshoots equipment, and supports incoming material review. The Specialist also maintains gowning and gloving qualifications for ISO-classified environments, reviews relevant records, uploads calibration data, enters data into LIMS and external laboratory portals, and provides input on procedure and form updates.

The position works Monday through Friday, 8:00 a.m. to 4:00 p.m. The listed pay range is $32–$34 per hour.

Requirements

• Bachelor’s degree in a science field, or three years of GMP/regulated-industry-related experience, or a combination of education and equivalent 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.
• Demonstrate good laboratory practices and interpret laboratory data.
• Operate laboratory equipment and software systems.
• 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 and troubleshoot equipment issues to maintain proper operation.
• Maintain gowning and gloving qualification for ISO-classified environments.
• Collect environmental samples and escalate out-of-specification results.
• Understand ISO requirements for cleanroom classifications and identify out-of-specification results during testing.
• Evaluate data, identify out-of-specification results, and accurately review laboratory, quality control, and calibration data.
• 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, escalate discrepancies to management, and communicate with external laboratories to resolve sample-submission discrepancies.
• Review cleaning documentation, autoclave logs, chemical make-up logs, and other documentation used for EM 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