Catalent, Inc. is looking to hire a Quality Assurance Associate to create a culture of quality, compliance and continuous improvement, which meets the government, customer and business requirements. The Quality Assurance Associate’s focus will be on prevention rather than detection of quality issues.
Requirements
- Advanced computer skills in Microsoft Office Suite. (Outlook, Excel, Access, Word)
- Experience working in a manufacturing, pharmaceutical and/or GMP facility is an asset.
- The employee's role frequently involves sitting and utilizing hands and fingers for tasks such as handling, feeling, and keyboard manipulation, necessitating manual dexterity.
- Occasionally, the position requires standing, walking, reaching, bending, twisting, stooping, kneeling, crouching, or crawling, alongside close vision capabilities and potential exposure to chemicals.
Responsibilities
- Performs In-Process Batch review of documentation and ensures all product has been manufactured in compliance with cGMPs and SOPs.
- Assists in the initiation of all manufacturing events and deviations as reported by the production departments.
- Ensures that all product which has been identified as potentially having a quality issue is acceptable for release, and the reports have been updated accordingly.
- Performs line clearance verifications of equipment and processing areas during changeovers from one type of product to another type of product — may include testing/verification of vision equipment.
- Acts as QA representative on shift in decision-making and issue resolution, escalating serious issues to production management and QA management as required.
- Issues, reviews and files various logs from areas of operation — includes equipment log, Temp/RH logs, etc.
- Monitors GMP compliance in the operating areas to assist in maintaining inspection readiness.
Other
- This position is 100% on-site at the Windsor site.
- Coaching/training operators and supervisors on proper documentation practices on cGMP requirements.
- Strong analytical skills and interpersonal skills.
- Extremely detailed oriented.
- Excellent communication skills — verbal and written.
- Able to work independently with minimal supervision.
- Participates in special projects as required in other areas of quality and compliance and must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met.
