Description

Position Summary & Responsibilities:

The normal working hours for this role is 7:00am - 7:30pm working a 2-2-3 rotation schedule. This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Biochemistry Analyst 2 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. Quality
Ensures all testing documentation is completed in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP requirements.Ensures review of laboratory testing is done in compliance with SOPs and is completed in a timely manner.Maintains compliance with SOPs, GLP, GMP, and HSE requirements.Prepares for regulatory, customer, and internal audits of Biochemistry laboratory areas.
Preparation includes review of logbooks for completion, instrument calibration checks, checking material expirations, and general cleanliness of laboratory area.Executes laboratory investigations as assigned by management in compliance with procedures.Provides input for laboratory investigations and documents invalid test results in compliance with procedures.Leadership
Leads as trainer for Quality Control testing and instrument maintenance.Troubleshoots simple to moderate Biochemistry laboratory equipment related issues.Documentation/Training
Enters data into the laboratory information management system (LIMS) and applicable paper-based data sheets. Assists with LIMS data entry to support LIMS maintenance and validation activities.Assists with revisions to QC department standard operating procedures (SOPs) as directed by management.Ensures personal training is maintained to current department processes and procedures.Trains teammates on Biochemistry laboratory testing and procedures.Obtains status as a certified trainer for applicable laboratory testing processes.Safety: Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.Continuous Improvement
Participate in continuous improvement activities.Participate in improvement initiatives as directed by management.6S: Maintain the laboratory and other specific testing areas of responsibility in a well-organized, clean, and tidy manner at all times, in compliance with cGLP.Other Duties
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 2+ years of experience in a regulated laboratory environment, Chemistry or Biochemistry lab experience is highly preferred.
In lieu of a Bachelor’s Degree, a high school diploma/GED with 6+ years of experience OR an Associate’s Degree with a minimum of 4+ years of experience working in a regulated laboratory environment are also acceptedTechnical writing experience is highly desired - Nonconformance, Laboratory Investigative Reports, CAPAs, Deviations, and SOPsExperience troubleshooting equipment and instrumentation is highly preferred (HPLC, GC, PH, UV-VIS, or similar)Technical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP).Experience with chemistry or biochemistry testing, knowledge of USP and EP/BP method/validation regulations.Experience participating in the management of regulatory audits (i.e. FDA, MDSAP, ISO, OSHA, EPA, etc.).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.).

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