QC Biochemistry Analyst 3 - Night Shift
Job Summary
Job Description
The QC Biochemistry Analyst 3 is responsible for routine Biochemistry testing, acting as a subject matter expert for laboratory instrumentation and processes. Responsibilities include performing and documenting test results, ensuring compliance with SOPs, GLP, GMP, and HSE requirements, and preparing for audits. The analyst also leads training, troubleshoots equipment issues, and participates in continuous improvement activities and investigations. This is a night shift position with a 2-2-3 rotation schedule.
Must have:
- Bachelor's degree with 4+ years of regulated lab experience
- Experience in chemistry or biochemistry lab is highly preferred.
- Technical writing experience is highly desired for reports.
Good to have:
- Troubleshooting experience with equipment and instrumentation.
- Experience with relevant chemistry or biochemistry techniques.
- Knowledge of USP and EP/BP method/validation regulations.
2 skills required
Job Details
Position Summary & Responsibilities:
The normal working hours for this position are NIGHT SHIFT 7:00pm - 7:30am working a 2-2-3 rotation schedule.
The QC Biochemistry Analyst 3 role is responsible for routine Biochemistry testing and participation as a subject matter expert for laboratory instrumentation and processes.
- Leadership
- Serves as a subject matter expert for Quality Control instruments and processes.
- Provides guidance and input as a certified co-investigator for Laboratory Incident Reports.
- Leads as a mentor and trainer for Quality Control testing, instrument maintenance, investigational writing, and other laboratory processes.
- 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.
- 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.
- Participates in regulatory audits as a subject matter expert as needed.
- Executes laboratory, non-conformance, and CAPA investigations as assigned by management in compliance with procedures.
- Maintains status as a certified investigator for Out of Specification investigations.
- Provides input for laboratory investigations and documents invalid test results in compliance with procedures.
- 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.
- Recommends and authors revisions to QC department standard operating procedures (SOPs) and executes in implementation.
- Ensures personal training is maintained to current department processes and procedures.
- Trains and mentor’s teammates on Biochemistry laboratory testing, processes, and procedures.
- Maintains status as a certified trainer for 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.
- Identify areas of deficiency and implement practices to improve employee safety, ergonomics, workflow/process design, etc.
- Lead 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 4+ years of experience in a regulated laboratory environment, Chemistry or Biochemistry lab experience is highly preferred.
- Master’s degree with 2+ years of experience in a regulated laboratory environment, Chemistry or Biochemistry is preferred or PhD, in a related field, with 0 years of experience also accepted
- In lieu of a Bachelor’s Degree, a high school diploma/GED with 8+ years of experience OR an Associate’s Degree with a minimum of 6+ 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 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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