Title: Manager, Quality Assurance
Company: Biotech Company
Location: CA, MA, PA, NJ, NC
Type: Permanent Role
Notes: No Corp to Corp
- Authors and reviews SOPs and policies. Create and establish process and procedures to ensure compliance and adherence to regulations and cGMP operations.
- Identifies, classifies and reports deviations, as appropriate and typically works on more complex minor and/or major deviations. Oversees execution of remediation/CAPA activities required to continue production, move a process to the next mile stone. Works closely with others to determine root cause and potential preventative/corrective actions. Ensure timely closure of investigations.
- Responsible for providing quality oversight to the change management system for change controls related to filling process of Drug Product. This includes providing plan creation oversight, verifying that changes adhere to SOPs and regulatory compliance.
- Ensures all specifications are met and that applicable requirements are completed and acceptable.
- Participate in quality oversight of manufacturing and testing, real-time observations of activities.
- Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems.
- Participate in internal audits for compliance with SOPs, GMPs, and regulations.
- Other activities as deemed necessary
- Bachelors or Master's degree (engineering or scientific discipline)
- Quality assurance experience in pharmaceutical industry providing oversight to Drug Product filling activities 8-10 with BS degree, 5-8 years of experience with MSdegree or 0-2 years of experience with PhD degree
- Ability to translate complex issues into a meaningful set of recommendations
- Demonstrated knowledge of cGMPs in a manufacturing environment
- Strong independent judgement and decision-making abilities
- Demonstrated problem detection and problem resolution skills
- Must possess demonstrated organizational skills
- Must possess excellent verbal and written