Principal Associate - QA

Key Responsibilities:
- Ensure appropriate execution of Quality Systems to sustain cGMP compliance.
- Ensure document control and data integrity for packaging instructions and cGMP standards.
- Review/approve/release batch records.
- Create/verify Certificates of Analysis.
- Provide quality support for packaging operations.
- Investigate, review/approve deviation investigations.
- Review/approve change controls, protocols, and master label proofs.
- Review/approve allowable dating, stability justifications, and retest dating for clinical trial (CT) materials.
- Provide quality oversight for Collaboration Partners as needed.
- Assist with regulatory body audits and site self-inspections to ensure cGMP compliance.
- Provide guidance to counterparts within the organization.

Basic Requirements:
- Bachelor of Science degree in a STEM field, or equivalent experience.
- Minimum 3–5 years of experience in pharmaceutical manufacturing (CT packaging experience preferred).

Additional Preferences:
- Strong knowledge of cGMPs, Quality Systems, and FDA Regulations.
- SAP power user experience.
- Standard Operating Procedure (SOP) writer experience.
- Strong oral and written communication; demonstrated interpersonal and networking skills.
- Ability to gather, edit, organize, and summarize information from multiple sources.
- Ability to influence team interactions and lead initiatives.
- Attention to detail; ability to work under time pressure with good judgment under minimal supervision.
- Excellent teamwork skills.

Other Information:
- Onsite position in Indianapolis, IN; onsite presence required the majority of the time.