Analyst (HPLC), Quality Control

Avid Bioservices • Tustin, CA

31d • $27 - $34

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 (HPLC), Quality Control will perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment. This position requires a strong background in HPLC and supports/leads continuous improvement initiatives.

Requirements

• BS in chemistry or biology or related field plus 2-4 years industry experience 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 have strong HPLC, Analytical Biochemistry and Chemistry experience.
• Must also have experience with most if not all of the following: protein characterization, electrophoresis, chromatography (normal phase, reverse phase, size exclusion, ion exchange, etc), aseptic techniques, assay and validation/qualification.

Responsibilities

• Perform and review routine assays for HPLC and CE (Capillary Electrophoresis) with strict adherence to written analytical test procedures.
• Perform aseptic sampling, visual inspection, gowning and working in clean room areas, 5S methodology.
• Review, revise and write test methods, standard operating procedures and perform trending analysis.
• In addition to performing QC testing, the Analyst may be designated as study lead for 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 to ensure laboratory is in compliance with current Good Manufacturing Practices.
• Demonstrate and provide evidence to FDA officials that the laboratory operations conform to code of federal regulation.
• Support continuous improvement initiatives by ensuring training relating to test methods, standard operating procedures, are up to date to comply with current good manufacturing practices.
• Utilize Instruments software to perform calculations to minimize errors and eliminate time allocation for manual calculations.
• Perform 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.
• Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 251-500 employees