Responsibilities

• Work with the test facility manager to implement the quality management system for the GLP/GMP bioanalysis organization.
• Provide comprehensive support in quality assurance, such as establishing Standard Operating Procedures (SOPs), reviewing study plan, auditing studies, issuing Quality Assurance (QA) statements.
• Perform QA audits, inspections (internal/external) and monitoring procedures against standard operating procedures, methods, protocols/plans, guidance, and/or regulations, as applicable
• Hosting client and regulatory inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as required
• Active participation and identification of compliance gaps to ensure that the organization and studies are conducted in compliance with pertaining regulatory authorities.

Qualifications

• Bachelor's degree in biology, chemistry, biochemistry or a related field and a minimum of 5 years of experience in the field or in a related field
• Minimum of 2-year experience working in an environment subject to FDA GLP/GMP regulations
• Experience in biologics bioanalysis is a plus.

Skills

• Internal and/or external GLP/GMP auditing experience
• Ability to work in fast paced environment where multiple projects are in process and must be completed in a timely manner
• Excellent oral and written communication skills

Job Type

• Full-time

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule

• 8 hour shift

Work setting

• In-person

Education

• Bachelor's (Preferred)

Experience

• GLP QA: 2 years (Required)
• GMP QA: 2 years (Required)