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Position Summary & Responsibilities:

The normal working hours for this role is NIGHT SHIFT 7:00pm - 7:30am 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 in Biology, Chemistry or Biochemistry with 2+ years of experience in a regulated laboratory environment, Chemistry or Biochemistry lab experience is highly preferred.

+ Master's degree or PhD with 0 years of experience also accepted

+ 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 accepted

+ Technical writing experience is highly desired - Nonconformance, Laboratory Investigative Reports, CAPAs, Deviations, and SOPs

+ Experience 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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