Description

Position Summary & Responsibilities:

The normal working hours for this role are anticipated to be 3rd Shift: Sunday - Thursday from 11:00pm - 7:30am. 

The QC Biochemistry Lead Analyst 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. This role is responsible for front-line leadership of a Quality Control team engaged in the execution of routine biochemistry testing per standard operating procedures. Tests may include raw materials, intermediates, finished goods, and stability samples submitted to the laboratory.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.Obtains and Maintains status as a certified Investigator for both nonconformances and out of specification investigations.Mentors more junior team members on laboratory investigations and invalid test results in compliance with procedures.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.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.Obtain and maintain status as a certified trainer, and assist with annual re-certification of other laboratory analysts.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 a regulated laboratory environment, Chemistry or Biochemistry lab experience is highly preferred.
A high school diploma/GED with 12+ years of experience in a regulated laboratory environment also acceptedAssociate’s Degree with 8+ years of experience in a regulated laboratory environment also acceptedBiochemistry or Chemistry lab experience is highly preferred.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 chemistry or biochemistry testing, knowledge of USP and EP/BP method/validation regulations.Experience with applicable instrumentation and troubleshooting.

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