QC Lead Analyst - Biochem

Position Summary:

Provides direction and general guidance in the Quality Control laboratories to ensure the quality of the bioMérieux products are appropriately measured and monitored through the use of relevant quality systems. Support routine tests per standard operating procedures. Tests may be raw materials, intermediates, environmental samples, finished goods, or stability samples submitted to the laboratory.

Responsibilities:

• Coordination with QC Support personnel for scheduling of QC testing and/or inspection of raw materials, in-process samples, finished product samples, and environmental samples; delegates tasks to ensure staff completes testing on time and with acceptable quality.  Forecasts sample load and creates/reviews testing schedule.
• Support routine testing of samples submitted to the laboratory.
• Documents all test results in compliance with procedures and GDP requirements.
• Ensures that staff executes and documents all testing in compliance with approved procedures.  Trains staff and ensures compliance with training procedures. Ensures that all testing is performed on laboratory instruments that are appropriately validated, calibrated, and monitored for compliance.  Coordinate and perform required calibration and maintenance tasks in the lab.
• Executes laboratory, nonconformance, and CAPA investigations as assigned by management and in compliance with procedures. 
• Performs GMP review of test data to ensure that test results meet all specifications.  Trend data and analyze trends.  Troubleshoot laboratory issues related to assays, methods, instruments, and equipment and recommend potential corrective and/or preventive actions and implements within the laboratory.  Performs testing as assigned by management.
• Ensures laboratory is functioning in compliance with SOPs, GLP, GMP, and HSE requirements.  Perform safety and compliance audits of the laboratory and assists with activities to address audit findings.  Identify and implement initiatives for increasing laboratory compliance, safety, and efficiency.
• Participates and provides appropriate team support in cross-function activities (e.g., method transfers, method validations, and cross-functional projects)
• Recommend and implement revisions to standard operating procedures.
• Maintains personal training file. Responsible for training of other analysts as directed by management.
• Perform any additional job related duties as requested.

Studies and Experience:

• BS with a minimum of 6 years relevant laboratory technique and quality principle experience required or Master degree with ≥ 2 years of relevant laboratory technique and quality principles.
• Demonstrated ability to critically think and efficiently trouble-shoot technical issues in a laboratory environment required
• Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills.
• In depth knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.).
• Experience participating in the management of regulatory audits (i.e. FDA, MDSAP, ISO, OSHA, EPA, etc.).
• Technical writing experience preferred
• Validation and Project Lead experience preferred

Skills and Qualifications:

• Strong organizational skills, the ability to prioritize work and manage multiple tasks independently.
• Excellent and effective verbal and written communication skills.
• Proven ability to problem solve/troubleshoot and provide solutions under minimal supervision.
• Good leadership and communication skills; Teamwork orientation.
• Ability to read, understand, and execute standard operating procedures related to the assigned area of responsibility.
• Able to assess safety and environmental risks to ensuring tasks adhere to HSE Management System