Quality Control Specialist

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

Overview

The Quality Control (QC) Specialist provides support across multiple quality control functions to ensure compliance with established quality standards and regulatory requirements. The role performs environmental sampling and documents results, reporting atypical conditions to management. The QC Specialist performs titration testing, inspects critical supplies, prepares documentation for supervisory approval, and supports the organization of 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.

Shift: Monday through Friday 8AM-4PM

Pay Range: $32-$34/hr.

Responsibilities

• Performs Quality Control tasks across clean rooms, laboratories, incoming material areas, QC sample rooms, and calibration systems.
• Analyze samples per approved OPs/Wls and ensure methods meet holdtime requirements.
• Reconciles samples and documentation in accordance with MTF documentation procedures.
• Collaborates with R&D, Supply Chain, internal laboratories, Quality Engineering (QE), and Process Engineering (PE) on laboratory studies, sample management, and incoming raw material inspection documentation.
• Perform environmental and chemical testing. Troubleshoots equipment issues to maintain proper operation.
• Maintain gowning and gloving qualification for ISO-classified environments
• Collect environmental samples and elevate out-of-specification results
• Understand ISO requirements for classifications of cleanrooms and identify out of specifications during testing.
• Evaluates data, identifies out of specifications, accurately reviews data pertaining to 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. Conducts measurements, records data accurately, and verifies that materials meet all specified requirements prior to approval.
• Coordinate sample packaging and shipping; elevate discrepancies to the management.Communicate with external laboratories to resolve any sample submission discrepancies.
• Reviews cleaning documentation, autoclave logs, chemical make-up logs, and other documentation used for EM release criteria. Escalates concerns to management.
• Upload calibration data into Blue Mountain. Escalates calibration discrepancies to equipment owners and designees.
• Enter data accurately into LIMS and external laboratory portals.
• Provides input on updates to OPs, Wis, and forms.
• Performs additional duties, as assigned.

Qualifications

• Bachelors in Science field or 3 years GMP/Regulated Industry related experience or Combination of Education and/or Equivalent Work Experience
• 2 Years Quality Assurance or Quality Control experience in GMP or FDA regulated industry.
• Maintain qualification per the gowning/gloving procedure for entrance into the ISO classified areas. Demonstrate good laboratory practices, interpret laboratory data.
• Operate laboratory equipment and software systems.
• Ability to recognize and elevate atypical results, equipment issues, or documentation discrepancies Effective written and verbal communication skills.
• Must be proficient in data entry, Microsoft Outlook, Word, and Excel.

Benefits Information

At MTF Biologics we provide comprehensive benefits and resources to support our employees physical, emotional, and financial health.

• 4 weeks Paid Time Off (PTO)
• Paid Holidays
• Medical, Dental, Vision Insurance and Prescription Drug Insurance
• 401K plan with company match
• Short & Long Term Disability
• Life & Accidental Death Insurance
• Tuition Reimbursement
• Health Care/Dependent Care Flexible Spending Accounts
• Adoption Assistance
• Voluntary Benefits (e.g., Pet Insurance, Legal, home and auto insurance)
• Sword Health (at home Physical Therapy)