Quality Control Specialist

Quality Control Specialist

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.
• Analyzes samples per approved OPs/Wls and ensures methods meet hold-time 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.
• Performs environmental and chemical testing. Troubleshoots equipment issues to maintain proper operation.
• Maintains gowning and gloving qualification for ISO-classified environments.
• Collects environmental samples and escalates out-of-specification results.
• Understands ISO requirements for classifications of cleanrooms and identifies out of specifications during testing.
• Evaluates data, identifies out of specifications, accurately reviews data pertaining to laboratory, quality control, and calibration data.
• Provides data, documentation, and observations to support investigations and corrective actions led by QC Management or Quality Engineering.
• Supports 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.
• Coordinates sample packaging and shipping; escalates discrepancies to management. Communicates 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.
• Uploads calibration data into Blue Mountain. Escalates calibration discrepancies to equipment owners and designees.
• Enters 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.
• Maintains qualification per the gowning/gloving procedure for entrance into the ISO classified areas. Demonstrates good laboratory practices, interprets laboratory data.
• Operates laboratory equipment and software systems.
• Ability to recognize and escalate 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)