Specialist Manufacturing

NO CANDIDATES FROM AMAGJP00014542.

New Albany, OH onsite hybrid 3 days a week remote the rest of the time.
Schedule: 8 AM - 5 PM local hours.


The ideal candidate will be a proactive and engaged quality professional with hands-on ownership of quality records, including CAPA and change control. They will be familiar with Veeva or TrackWise systems and come from a biotech (preferred) or medical device background. A Bachelor's or Master's degree is appropriate; PhDs may be overqualified. Strong communication, reliability, and critical thinking are essential. Please prioritize candidates who demonstrate genuine curiosity, initiative, and accurate hands-on experience.

The manager is seeking a tactical, detail-oriented Quality professional to support external-facing quality records related to raw material suppliers. The ideal candidate will have 3-5 years of hands-on experience managing deviations, change controls, and CAPAs using systems like TrackWise or Veeva. A strong grasp of root cause analysis and investigation review is essential. Candidates should have a background in biotech or medical device industries, with the ability to operate in a fast-paced, remote environment. Bachelors Degree is best but associate-degree holders with deep experience (10+ years) will be considered. Overqualified individuals (e.g., former directors or PhDs) and those without relevant quality records experience should not be submitted.

Quality records experience working with suppliers would be a home run candidate.
Basic project management skills required.

The Specialist Manufacturing is expected to own and execute under minor supervision all the processes related to deviations (minor and majors), Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control quality records. This Specialist Manufacturing will act as the External Supply representative across functional teams and drive closure of quality records in a timely manner. The Specialist Manufacturing, External Supply owns and manages quality records originating from manufacturing sites across the *** network. In addition, this role will be the main External Supply quality record owner point of contact for ***'s New Albany, OH site.
Responsibilities:

- Address and close quality records (Deviations, Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control) under the company's quality management system procedures and ensures compliance with regulatory agency requirements.
- Monitors and investigate deviations owned by External Supply and implements corrective / preventive actions. Partner cross-functionally across the site to ensure maturity and execution of robust Deviations / CAPA process
- Build and present quality records summaries for Senior Management review. Provide timely and comprehensive process and status updates to senior management
- Support ***'s New Albany, OH site as the external supply quality record owner main point of contact and collaborates with the site and technical teams to evaluate observed supplier related defects.