Note: The job is a remote job and is open to candidates in USA. Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of clients and improve patient outcomes. The Analyst (HPLC), Quality Control will perform testing and sampling to support manufacturing and validation processes in a GMP environment, while also leading continuous improvement initiatives.
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
Skills
- 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
Benefits
- Performance-based bonuses
- Health, dental, and vision insurance
- 401(k) matching
- Paid time off
- Opportunities for career growth and development
- A supportive and inclusive work environment
Company Overview
Company H1B Sponsorship