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Position Summary & Responsibilities:

The normal working hours for this role will be Monday - Friday 1st shift, although training may be on a 12 hour rotation. The QC Biochemistry Lead Analyst is responsible for front-line leadership of a Quality Control team engaged in the execution of routine biochemistry testing per standard operating procedures. This role will be in a key position in the Biochemistry laboratory performing testing of Description, pH, FTIR, Osmolality, Moisture Analysis, Solubility, Loss on Drying, Resin Ratio, Reflectance, and pO2 Headspace Analysis, HPLC.

+ Leadership

+ Serves as a back-up to the Manager, QC Biochemistry/BCID (or higher) when needed.

+ Develops the biochemistry testing team.

+ Inspires and motivates the biochemistry testing team to achieve top performance as a team.

+ Inspires and promotes self-growth and internal development within the team.

+ Assists in management of daily activities, including scheduling testing activities and leading daily shift tie-in meetings.

+ Generates reports, charts, and KPI’s by interpreting data to identify problems and proceed with proper decision making.

+ Conducts team standing meetings daily and as needed and keeps records/documentation of what was discussed. Performs all work in compliance with company quality procedures and standards.

+ Testing

+ Performs routine testing of samples submitted to the laboratory.

+ Manages the scheduling of finished goods and special testing requests submitted to the biochemistry laboratory.

+ Responsible for inventory management and ordering/stocking laboratory supplies.

+ Maintains laboratory equipment in compliance with procedures and GLP requirements. Routinely checks laboratory equipment and associated equipment logs to ensure proper operation.

+ Troubleshoots simple to moderate biochemistry laboratory equipment related issues.

+ Quality

+ Ensures all testing documentation is completed in an accurate, thorough and timely manner. Documents test results in compliance with procedures and GDP requirements.

+ Performs and/or oversees self-audits of biochemistry laboratory areas (including storage areas). Acts as a Subject Matter Expert in federal and customer audits.

+ Executes laboratory, non-conformance, and CAPA investigations as assigned by management in compliance with procedures.

+ Mentors more junior team members on laboratory investigations and invalid test results in compliance with procedures.

+ Documentation/Training

+ Enters data into the laboratory information management system (LIMS). Assists with LIMS data entry to support LIMS maintenance and validation activities.

+ Recommends and authors revisions to QC department standard operating procedures (SOPs) and assists in implementation.

+ Ensures overall team training is maintained to current department processes and procedures.

+ Trains and mentors teammates on biochemistry laboratory testing, processes, and procedures.

+ Safety

+ Ensures team complies with all safety policies and procedures at all times.

+ Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.

+ Continuous Improvement

+ Lead and promote continuous improvement through team and individual initiatives.

+ Identify areas of deficiency and implement practices to improve employee safety, ergonomics, poor workflow/process design, etc.

+ Serve on cross-functional project teams to increase QC testing quality, decrease operational costs, and improve biochemistry department efficiency/productivity.

+ 6S: Maintain all biochemistry laboratory areas in a well-organized, clean, and tidy manner at all times in compliance with cGLP.

+ Other Duties

+ Contributes to team goal development, communication, and status tracking by providing feedback to the direct manager for the GPS process.

+ Work with other departments and assist with executing validation protocols associated with biochemistry laboratory equipment, associated software, and procedures including revalidation as scheduled or required to maintain systems in a validated state.

+ Performs additional job-related duties as assigned by management.

Education, Skills, & Experience:

+ Bachelor's Degree with 4+ years of experience in Chemistry or Biochemistry in a regulated laboratory environment OR a Master’s degree with 2 years of experience in Chemistry or Biochemistry in a regulated laboratory environment OR PhD with 0 years of experience in Chemistry or Biochemistry in a regulated laboratory environment are all accepted

+ In lieu of a Degree, a high school diploma/GED with a 12+ years or an Associate’s Degree with 8+ years of progressively responsible experience working in a regulated laboratory environment, Biochemistry or Chemistry also accepted

+ Experience with chemistry or biochemistry testing, knowledge of USP and EP/BP method/validation regulations.

+ Technical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP).

+ 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.).

+ Experience with applicable instrumentation and troubleshooting.

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