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Manufacturing Specialist

New Albany, OH 43054

Posted: 11/04/2025 Employment Type: Contract Job Category: Manufacturing Job Number: 622737 Is job remote?: No Country: United States

Job Description

Target PR Range: 29-39/hr
*Depending on experience

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 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 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.

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.
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About New Albany, OH

Discover exciting job opportunities in the enchanting area of New Albany, Ohio! If you're seeking a vibrant location with endless growth possibilities, look no further. Known for its picturesque landscapes, charming boutiques, and thriving arts scene, New Albany offers a unique blend of small-town charm and big-city amenities. Imagine working just a short drive away from the renowned New Albany Country Club, the McCoy Center for the Arts, and the delicious New Albany Farmers Market. Embrace the chance to be part of a community that values innovation, culture, and a high quality of life. Explore our job listings today and take the first step towards a fulfilling career in this captivating region!