Quality Control Analyst

The Quality Control Analyst performs routine and non-routine quality control testing of raw materials, in process materials, and finished medical device products. The role supports stability programs, process and method validation, method transfer, and development activities within a regulated Quality Management System (QMS). The Quality Control Analyst contributes directly to product safety, quality, and regulatory compliance throughout the product lifecycle. This role reports to the QC Supervisor.

• Execute Quality Control activities in compliance with ISO 13485, GMP, GLP, and internal quality system requirements.
• Perform routine and non-routine testing of raw materials, in process materials, and finished products in accordance with approved specifications, test methods, and production schedules.
• Review, verify, and approve laboratory data, test results, and supporting documentation as per Good Documentation Practices (GDP) and Good Laboratory Practices (GLP)
• Support product disposition activities by reviewing test results against acceptance criteria and assisting with batch and material release documentation as per QMS requirements.

• Conduct routine and non-routine tests for stability studies using approved procedures/protocols.
• Conduct non-routine testing to support process/equipment validation, investigations, change controls, and other quality related activities as assigned.
• Escalate atypical results, conditions and deviations to Supervisor or Sr. QC Analyst
• Participate and support investigations such as OOS, Deviations, etc. by performing additional testing, review and root cause problem solving.

• Manage QC inventory, including release and status control of materials, reagents, and test articles; ensure traceability of consumables and retention samples.
• Ensure laboratory records are prepared, reviewed, and maintained in compliance with document control and record retention requirements.
• Assist in drafting, reviewing, and revising SOPs, forms, validation protocols, and reports in accordance with quality system procedures.
• Order laboratory supplies and ensure proper receipt, inspection, identification, and labeling of materials.
• Perform and document routine laboratory equipment checks and maintenance; report equipment issues per deviation and nonconformance procedures.
• Support maintenance, calibration and troubleshooting of laboratory equipment.
• Participate in departmental, quality, and cross functional meetings as required.
• Perform other duties as assigned to support operations.

• 1-3 years of work experience in a Quality Control Laboratory within a regulated environment (Medical Devices, Pharmaceutical, Cosmetics, etc.)
• Microbiology experience preferred.
• University Degree or greater in a Scientific discipline (Chemistry, Microbiology, Biotechnology or related field)
• Good understanding of Good Laboratory Practices (GLP) and Good Documentation Practices.
• Working knowledge of analytical techniques (e.g., wet chemistry, HPLC, spectroscopy, chromatography, Endotoxin Testing, PCR, Aseptic Technique).
• Strong written and oral communication skills.

Demonstrated ability to apply the following behavioral competencies on the job:

• Teamwork:
  Works effectively within cross functional teams.
• Written Communication: Produces clear, accurate, and compliant documentation.
• Problem Solving: Identifies, analyzes, and resolves quality related issues under appropriate supervision.
• Organization & Planning: Manages tasks methodically to meet timelines and compliance requirements.
• Flexibility: Adapts to changing priorities, regulatory expectations, and operational needs.

• Experience in a regulated laboratory environment (medical device, pharmaceutical, or Cosmetics).
• Exposure to wet chemistry or advanced analytical testing techniques.
• Experience with inventory control and material status systems.
• Experience preparing or supporting controlled technical documentation (SOPs, protocols, reports)

Required to work about 50% in a laboratory environment with computer work required to support QMS activities.