Quality Control Associate

The Quality Control Associate – Reagent Manufacturing is a key member of a team that performs raw material and finished goods testing. The role involves reviewing, generating, and signing off on quality documentation and interfacing with highly complex systems and controls in an ISO 13485 and cGMP manufacturing environment.

• Analytical and problem solving
• Great communication and organization skills
• Able to lift 20‑25 pounds and stand for long periods of time

• Maintain areas in a high state of inspection preparedness by maintaining equipment, records, and laboratory environment to comply with regulatory requirements using current regulations and Operating Procedures (OP).
• Maintain production documents and investigate out of specification (OOS) incidents, working independently with general guidance from senior team members.
• 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 from raw material to finished goods.
• Maintain records and QC lab environment to comply with cGMP, OP and regulatory requirements.
• Perform routine maintenance of laboratory equipment as outlined by operating procedures.
• Assist in coordinating vendor activities for user‑maintained laboratory equipment.
• Perform regular laboratory and manufacturing environmental monitoring testing.
• Manage laboratory supply ordering and inventory to support the QC laboratory and adhere to inventory control processes (TECO, cycle counts, etc.), including indirect materials and tissue Kanbans.
• Foster and follow an established safety culture, environmental guidelines, and procedures for all work performed.
• 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.
• Assist in 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 activities.

• Maintain Right to Operate and ensure all processes are performed safely, addressing and escalating any potentially unsafe hazards.
• Navigate and understand the quality system and escalating issues.
• Accurately perform tasks in a regulated environment (OSHA, NMPA, FDA, etc.).
• Document all transactions and production instructions with accuracy related to receipt, quarantine, storage, and disbursement of materials as they relate to FDA, OSHA, QSR, ISO, GMP and Roche policies.
• Ensure equipment complies with calibration standards.
• Conduct out‑of‑specification investigations and support non‑conformance investigations, reworks, and corrective actions.
• Act as QC representative in reviewing and providing feedback on document changes, including redlines from external teams.
• Adhere to 95% or above internal training compliance and maintain complete and accurate records including daily metrics.

• Lead 6S activities, gather/meet cycle times, and develop/follow standard work to identify and implement process improvements.
• Participate and contribute in team meetings.
• Participate in process improvement projects and collect data for daily metrics to support operational excellence initiatives.
• Perform other duties as assigned.

• Proactively collaborate with peers and other functions to ensure targets are achieved.
• Assist in onboarding by training new employees and contractors.
• Provide suggestions to improve work processes and laboratory equipment.
• Engage in cross‑functional technical activities such as quality investigations and product…