QC Analyst 2 - Night Shift
Job Summary
Job Description
The QC Biochemistry Analyst 2 role operates on a night shift (7:00 PM - 7:30 AM) with a 2-2-3 rotation schedule in a fast-paced, FDA-regulated medical device environment. Responsibilities include performing various biochemistry laboratory tests such as Description, pH, FTIR, Osmolality, Moisture Analysis, Solubility, Loss on Drying, Resin Ratio, Reflectance, and pO2 Headspace Analysis using HPLC. The role involves ensuring accurate and timely documentation, maintaining compliance with SOPs, GLP, GMP, and HSE requirements, preparing for audits, and executing laboratory investigations. The analyst will also act as a trainer for QC testing and instrument maintenance, troubleshoot equipment issues, enter data into LIMS, assist with SOP revisions, and maintain personal training current. Additionally, the role requires appropriate use of PPE, participation in continuous improvement activities, and maintaining laboratory organization in compliance with cGLP. Collaboration with other departments for validation protocols is also part of the duties.
Must have:
- Bachelor's degree in Biology, Chemistry or Biochemistry with 2+ years of experience
- Experience in a regulated laboratory environment
- Knowledge of chemistry or biochemistry lab techniques
- Understanding of quality principles (GMP/GLP)
- Experience with relevant chemistry or biochemistry testing
- Knowledge of USP and EP/BP method/validation regulations
- Experience managing regulatory audits
- Proficiency with data entry and analysis software (LIMS)
- Advanced technical writing skills
Good to have:
- Master's degree or PhD with 0 years of experience
- High school diploma/GED with 6+ years of experience
- Associate's degree with 4+ years of experience
- Technical writing experience (Nonconformance, Investigative Reports, CAPAs, Deviations, SOPs)
- Experience troubleshooting equipment (HPLC, GC, PH, UV-VIS)
- In-depth knowledge of Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE)
3 skills required
Job Details
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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