JOB SUMMARY:
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.
MAJOR RESPONSIBILITIES:
QC Testing and Documentation
- 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.
Stability, Validations and Investigations
- 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.
QC Support Tasks
- 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.
MINIMUM QUALIFICATIONS:
Technical Knowledge/Experience
- 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.
Behavioral
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.
PREFERRED QUALIFICATIONS:
- 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)
WORKING CONDITIONS:
Required to work about 50% in a laboratory environment with computer work required to support QMS activities.
