Senior QA Specialist

Job Responsibilities:

1. Uphold on-site quality standards at the GMP facility, supporting clinical phase manufacturing, batch record review, and resolution of quality issues.
2. Facilitate incoming raw material/excipient release, oversee document management, and contribute to training systems.
3. Ensure compliance with applicable regulations, guidelines, and internal procedures to maintain product quality.
4. Proactively promote GMP, GDP, and compliance concepts.
5. Support incoming raw material release and dispensing for batch production.
6. Assist Supply Chain and Manufacturing in CoA review, approval, and filing.
7. Oversee clinical phase manufacturing for GMP compliance, including batch record issuance, line clearance, QA presence on the floor, and material checks.
8. Support batch documentation review, deviations/investigations, change control, and issue resolution for Intermediate and Drug Product Disposition.
9. Participate in document life-cycle and training management, including initiation, document revision, approvals, distributions, and review and filing of training documentation.
10. Review documents for formatting, templates, completeness, and consistency. Assist in building and maintaining document templates. 
11. Support the maintenance of employee training records and department curricula development.
12. Actively contribute to the continuous improvement of quality systems.

Qualifications:

• Minimum of a BA/BS in a science-related field.
• 5 years of relevant work experience in the pharmaceutical, biotech, or medical device industry.
• Knowledge of Good Manufacturing Practices (GMPs) and Good Documentation Practices.
• Proficient in Microsoft Word, Excel, PowerPoint, SharePoint, and Smartsheet.
• Strong organizational, verbal, and written communication skills, with the ability to manage multiple tasks.
• Effective interpersonal communication skills and ability to work in a team environment.
• Flexibility to adapt rapidly to changing environments and circumstances.
• Strong troubleshooting and problem-solving abilities.