Analyst, Quality Control
About The Position
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Analyst, Quality Control will perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment. Perform and review routine assays for HPLC, ELISA/cell-based immunoassays, and/or electrophoresis (SDS-PAGE/IEF) with strict adherence to written analytical test procedures. Perform aseptic sampling, visual inspection, pH, conductivity, osmolality, and spectrophotometry. Review, revise and write test methods, standard operating procedures. In addition to performing QC testing, the Analyst may support validation projects, investigations, and method development projects. Other functions include but are not limited to writing study protocols and reports; training other analysts; working with other departments in developing, revising, and implementing QC procedures and policies. Knowledgeable of company cGMPs as well as industry regulations that apply to all job functions. Participate in regulatory inspections. Support continuous improvement initiatives. Other duties as assigned.
Requirements
- Bachelor’s degree in biology, biochemistry, chemistry or equivalent scientific field.
- A minimum of 2 years of relevant, hands-on experience working in a QC or analytical lab or equivalent combination of education/experience.
- Experience with analytical testing and equipment, writing reports/procedures/specifications, GMPs and regulatory audits are essential.
- Must be proficient with ELISA, Analytical Biochemistry or chemistry.
Responsibilities
- Perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment.
- Perform and review routine assays for HPLC, ELISA/cell-based immunoassays, and/or electrophoresis (SDS-PAGE/IEF) with strict adherence to written analytical test procedures.
- Perform aseptic sampling, visual inspection, pH, conductivity, osmolality, and spectrophotometry.
- Review, revise and write test methods, standard operating procedures.
- Support validation projects, investigations, and method development projects.
- Write study protocols and reports.
- Training other analysts.
- Working with other departments in developing, revising, and implementing QC procedures and policies.
- Knowledgeable of company cGMPs as well as industry regulations that apply to all job functions.
- Participate in regulatory inspections.
- Support continuous improvement initiatives.
- Other duties as assigned.
Benefits
- We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
- The compensation range for this role is $26.73-$28.00 hourly depending on experience and qualifications.
- Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
