QA Investigation Specialist

In this role, a typical day might include:
- Independently investigating non-conformances and preventing reoccurrences in support of manufacturing operations
- Preparing investigation reports with recommendations for medium/high severity non-conformances
- Analyzing and evaluating investigation information; summarizing findings and trends in investigation reports
- Communicating findings and recommendations at group meetings
- Reviewing completed batch records and logbooks in accordance with cGMP standards to support investigations
- Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards
- Monitoring production processes to acquire data in support of investigations and track efficiency of changes
- Participating in and/or leading cross-functional study teams to support results and investigations
- Gathering, trending, and analyzing process-related data to drive consistency and timeliness
- Documenting all training
- Training new employees on investigative processes and techniques
- Coordinating and/or leading cross-functional meetings with multiple departments

This role may be for you if you:
- Excel in a quality-driven organization
- Understand biologics manufacturing operations
- Are organized with strong attention to detail
- Can prioritize multiple assignments and changing priorities
- Can learn and utilize computerized systems for daily tasks

Gowning and Environment:
- Ability to wear full cleanroom attire (e.g., gown, mask, hairnet, safety glasses/shoes, latex gloves; use of sanitizing agents such as IPA during gowning)
- Ability to remove jewelry, make-up, and nail adornments when wearing cleanroom attire

Role:
- Bachelor’s degree in Life Sciences, Engineering, or related field
- Associate Specialist: 0–2 years relevant experience; Specialist: 2+ years; Senior Specialist: 5+ years (education may be substituted with proven experience)

Application instructions:
- Apply now.