Quality Analyst Jobs

About The Position

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.
• Strong written and verbal skills.
• Exceptional multitasking skills and attention to detail.
• Ability to build relationships with team members, clients, vendors, or suppliers.

Nice To Haves

• A "bring it on!" team player approach and an unshakable positive attitude.
• Ability to work overtime and/or weekends when necessary.

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

• base salary
• performance-based bonuses
• health insurance
• dental insurance
• vision insurance
• 401(k) matching
• paid time off
• opportunities for career growth and development
• supportive and inclusive work environment