QA Specialist III
About The Position
As a Quality Assurance Specialist III, you will serve as a key representative of the Quality Assurance organization, ensuring quality and compliance standards are maintained across aseptic manufacturing operations. This role provides the opportunity to partner closely with Manufacturing, Quality Control, Engineering, and support teams to support production activities, provide quality oversight, maintain cGMP compliance, and help deliver life-changing therapies to patients. The successful candidate will be responsible for quality decision-making, investigation support, batch record review, and driving compliance initiatives within a regulated GMP manufacturing environment.
Requirements
- Bachelor’s degree in a scientific, technical, engineering, or related discipline required.
- Minimum of 5 years of experience in a cGMP-regulated manufacturing environment and related Quality Assurance field.
- Previous Quality Assurance and/or Quality Control experience within pharmaceutical, biologics, cell therapy, or GMP manufacturing operations.
- Experience supporting investigations, deviations, root cause analysis, and quality system processes.
- Experience reviewing GMP documentation, batch records, and deviation records with strong attention to detail.
- Strong critical-thinking skills with the ability to make independent quality decisions in a fast-paced manufacturing environment.
- Proficiency with Microsoft Office applications.
- Strong communication, technical writing, time management, and cross-functional collaboration skills.
- Ability to manage multiple projects concurrently while maintaining a high level of quality and compliance.
Nice To Haves
- Knowledge of GMP regulations, including 21 CFR Parts 210, 211, and 820, as well as ISO quality standards and data integrity requirements preferred.
- Familiarity with aseptic manufacturing environments and cleanroom operations.
- Experience with TrackWise, DMS, SAP, and LIMS systems preferred.
Responsibilities
- Verify compliance with ISO, cGMP quality system requirements, FDA regulations, and other applicable regulatory guidance.
- Perform QA walkthroughs and work closely with Manufacturing and support groups to identify, investigate, and resolve quality and compliance issues.
- Provide independent quality oversight and make quality-related decisions based on regulatory and compliance knowledge.
- Review and approve Master Batch Records (MBRs), executed batch records, and supporting GMP documentation to support manufacturing operations and product release activities.
- Support and oversee investigations, deviations, environmental monitoring events, laboratory investigations, and root cause analysis activities.
- Provide quality support for aseptic manufacturing operations, including real-time decision making during production activities.
- Become gown-qualified and provide on-floor QA support within classified manufacturing environments.
- Manage multiple priorities and projects simultaneously while supporting quality system initiatives and continuous improvement efforts.
- Lead or support special projects and additional QA compliance activities as assigned by QA leadership.
Benefits
- A competitive compensation package.
- Performance-related bonus
- Medical, dental and vision insurance
- 401(k) matching plan
- Life insurance, as well as short-term and long-term disability insurance
- Employee assistance programs
- Paid time off (PTO)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
