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Manufacturing Specialist
Job Description
*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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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