Job Title: Specialist Manufacturing – External Supply Quality Location: New Albany, OH Work Arrangement: Fully Onsite Schedule: 8:00 AM – 5:00 PM (Local Hours) Duration: 6 Months (Possibility of Extension)
Top 3 Must-Have Skill Sets
Quality record ownership experience (Deviations, Supplier Investigations, CAPA, Change Control)
Knowledge of Veeva or TrackWise systems
Experience in the biotech industry
Job Description Role Summary The Specialist Manufacturing will support external-facing quality records related to raw material suppliers. This role focuses on managing and closing quality records such as deviations, CAPAs, supplier investigations, and change controls within the quality management system. The position will act as the External Supply representative across cross-functional teams and will be responsible for ensuring timely closure of quality records across manufacturing sites within the network. The role will also serve as the primary point of contact for external supply quality records for the New Albany, OH site, collaborating with site and technical teams to evaluate supplier-related defects and maintain compliance with regulatory and internal quality standards.
Key Responsibilities
Own and close quality records including deviations, CAPAs, CAPA effectiveness verifications, supplier event notifications and investigations (SICAR/EN), and change control records in compliance with company quality procedures.
Monitor and investigate deviations related to external supply and implement corrective and preventive actions.
Perform root cause analysis and support investigation reviews for quality events.
Collaborate cross-functionally with internal teams and suppliers to ensure timely resolution of quality issues.
Build and present quality record summaries and status updates for senior management review.
Serve as the primary External Supply quality record owner and point of contact for the New Albany site.
Partner with site and technical teams to evaluate supplier-related defects and ensure quality compliance.
Schedule and lead follow-up meetings with cross-functional partners and suppliers to drive closure of quality records.
Basic Qualifications Doctorate degree OR Master’s degree with 2 years of experience OR Bachelor’s degree with 4 years of experience OR Associate degree with 8 years of experience OR High School Diploma / GED with 10 years of experience.
Preferred Qualifications
3–5 years of hands-on experience managing deviations, CAPAs, supplier investigations, and change controls.
Experience working with TrackWise or Veeva quality management systems.
Experience within the biotech or medical device industry.
Experience working with quality records related to suppliers.
Knowledge of secondary packaging and device manufacturing.
Basic project management and stakeholder coordination skills.
Strong communication, reliability, critical thinking, and attention to detail
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 38.83/hr.
