Quality Control Associate

Job Description

Job Summary:

• The Quality Control Associate – Reagent Manufacturing will be an integral part of a team that performs raw material and finished goods testing.
• The individual will be responsible for review, generation, and sign-off of quality documentation.
• The role requires interfacing with highly complex systems and controls in an ISO 13485 and cGMP manufacturing environment.
• The associate will maintain areas in a high state of inspection preparedness by maintaining equipment, records, and laboratory environment in compliance with regulatory requirements and Operating Procedures (OP).
• Responsibilities also include maintaining production documents, investigating Out of Specification (OOS) results, and working independently with general guidance from senior team members.

Duties and Responsibilities:

• Perform inspection and testing of raw materials, in-process materials, and finished goods in a compliant manner.
• Document test results, complete batch records, document observations, and generate reports for qualification testing.
• Conduct data analysis of raw material, in-process, and finished goods test results.
• Generate compliant QC documentation as part of the Device History Record required for releasing items into inventory.
• Maintain records and QC lab environment to comply with cGMP, OP, and regulatory requirements.
• Perform routine maintenance of laboratory equipment outlined by operating procedures.
• Assist in coordinating vendor activities for user-maintained laboratory equipment.
• Perform regular laboratory and manufacturing environmental monitoring testing.
• Handle lab supply ordering and inventory management to support QC laboratory needs (TECO, Cycle counts, etc.), including indirect materials, tissue Kanban, and retain samples.
• Foster and follow an established safety culture, environmental guidelines, and procedures.
• Formulate reagents with high complexity for material testing processes.
• Act as QC representative in transferring processes from development to QC.
• Assist in testing raw materials for reliability and stability, process monitoring, and trending.
• Assist in collecting, interpreting, and communicating process metrics for recommended improvements.
• Assist in performing, reviewing, and/or generating validations for QC processes and laboratory equipment.
• Assist in the development and implementation of testing processes.
• Assist in reagent manufacturing activities unrelated to QC.

Quality and Safety, Compliance:

• Maintain Right to Operate and ensure all processes are performed in a safe and healthy manner.
• Escalate unsafe hazards and report incidents or near misses using safety reporting tools.
• Navigate and understand the quality system, escalating issues when required.
• Perform tasks accurately in a regulated environment (OSHA, NMPA, FDA, etc.).
• Document all transactions and production instructions with accuracy related to materials handling in compliance with FDA, OSHA, QSR, ISO, GMP, and company policies.
• Ensure equipment compliance with calibration standards.
• Conduct OOS investigations and support non-conformance, reworks, and corrective actions.
• Act as QC representative in document review and provide feedback on changes.
• Maintain 95% or above internal training compliance.
• Maintain accurate records, including daily metrics.

Continuous Improvement:

• Conduct 6S activities and develop/follow standard work.
• Identify and implement process improvements using lean tools.
• Participate in team meetings and process improvement projects.
• Contribute to data collection for daily metrics and operational excellence initiatives.
• Perform other duties as assigned.

Teamwork and Collaboration:

• Collaborate with peers and other functions to achieve targets.
• Assist in onboarding and training new employees and contractors.
• Suggest improvements for work processes and laboratory equipment.
• Engage in cross-functional technical activities such as quality investigations and product design transfer.
• Update and edit standard operating procedures.
• Work with vendors, planners, and departments to ensure seamless integration.
• Assist in executing complex projects.
• May act as proxy for QC Leadership when required.

Education and Experience:

• High School Diploma.
• Associate’s or Bachelor’s Degree in Science or Life Science discipline.
• 7 years’ work experience in regulated industry with HS Diploma.
• 3 years’ work experience with an Associate’s Degree.
• Entry level (<1 year) with a Bachelor’s Degree.
• Experience handling corrosive and biohazardous reagents.
• Experience in GLP, cGMP, or ISO regulated environments.
• Experience with 6S and Lean techniques.

Knowledge, Skills, and Abilities:

• Excellent oral and written communication skills.
• Strong data analysis, troubleshooting, and problem-solving skills.
• Hands-on laboratory experience.
• Accurate manual pipetting and measuring techniques.
• Attention to detail and strong organizational skills.
• Proficiency in Google Suite and other computer programs.
• Ability to meet deadlines and work effectively in teams.
• Proficiency in a wide range of moderate/high complexity lab techniques (titration, spectroscopy, protein analysis, tissue testing, etc.).

Physical Conditions & PPE Requirements:

• Requires gowning, hair net, safety glasses, gloves, and foot coverings.
• Ability to lift up to 25 lbs.
• Possible overtime and shift work depending on business needs.
• Ability to stand, walk, sit, kneel, bend, crouch for 4+ hours per day.
• Ability to push, pull, and lift 25 lbs. with repetitive hand/wrist movements.
• Good near visual acuity required.