Quality Control Specialist

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

Benefits offered by this job

4 weeks PTO

Medical, Dental, Vision Insurance

401K with company match

Life & Disability Insurance

Tuition Reimbursement

Job summary

Musculoskeletal Transplant Foundation is seeking a QC Specialist to support multiple QC functions, perform environmental sampling, titration testing, and inspect supplies. You will maintain accurate records in LIMS and logs, coordinating with internal and external labs while escalating discrepancies to management.

Shift: Mon-Fri 8AM-4PM. Pay Range: $32-$34/hr. This role emphasizes ISO-classified environment qualification and adherence to GMP/FDA requirements.

Qualifications

• Bachelor in Science or 3 years GMP/Regulated Industry related experience
• 2 years QA/QC experience in GMP or FDA regulated industry
• Maintain gowning/gloving qualification for ISO classified areas and demonstrate good laboratory practices
• Operate laboratory equipment and software systems; interpret data accurately

Responsibilities

• Perform Quality Control tasks across clean rooms, laboratories, and calibration systems
• Analyze samples per OPs/WIs and ensure hold time requirements
• Coordinate sample submissions with internal and external laboratories; escalate discrepancies to management
• Review and document data; support investigations and corrective actions led by QC Management or QE
• Maintain accurate logs and correspondence to ensure data integrity and traceability

Skills

GMP/regulatory experience

Data entry & record keeping

Communication skills

Laboratory software usage

Education

Bachelors in Science

Tools

LIMS

Microsoft Excel

Microsoft Word

Microsoft Outlook

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)