Quality Control Specialist

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

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 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.
• 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 escalate 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; escalate 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 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.