Catalent, Inc. is looking for a Quality Assurance Specialist to ensure compliance with applicable site procedures and regulations in their BioAnalytical Services business.
Requirements
- Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form
- Mathematical and scientific reasoning ability
Responsibilities
- Performs various audit activities including, but not limited to, audit of laboratory data, stability reports, technical reports, method validations, method transfers, laboratory facilities, etc. to assure compliance with applicable site procedures and regulations
- Perform review, approval and issuance of documents (e.g. Certificates of Analysis and Analytical Results Forms)
- Performs review and approval of analytical methods, specifications and protocols
- Follow Good Manufacturing Practices (e.g. GXP, GMP, GDP, etc.) as necessary to accomplish daily tasks
- Meet deadlines according to agreed timeframes and communicate adjustments as needed
Other
- A Bachelor's degree in STEM field is required with at least one year of basic work experience in a professional environment
- Associates Degree also accepted with a minimum of two years of related experience
- Strategy is focused on personal time management and efficiency
- Well organized with ability to multitask
- Ability to work effectively under pressure to meet deadline
