We're seeking a Specialist, Manufacturing to own and manage quality records across the manufacturing site network. In this role, you'll be the primary point of contact for quality records originating from the New Albany, Ohio facility.
You'll take the lead on all processes related to deviations (minor and major), CAPAs, Supplier Event Notifications and Investigations, and Change Controls. This position requires you to act as a representative for External Supply across various teams, driving the timely closure of all quality records.
Schedule: 1st shift, Mon.-Fri., 8 AM - 5 PM EDT
Flexible hybrid schedule, with three days on-site and the rest of the week remote.
location: New Albany, Ohio
job type: Contract
salary: $35.37 - 41.61 per hour
work hours: 9 to 5
education: Bachelors
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.
qualifications:
- Bachelor's degree in a relevant field.
- Strong quality background to support external-facing quality records related to raw material suppliers in the biotech or medical device industry.
- 3-5 years of hands-on experience in managing deviations, change controls, and CAPAs within a fast-paced environment.
- Proven experience with Veeva or TrackWise quality management systems.
- Strong background in the biotech or medical device industry.
- Demonstrated proficiency in root cause analysis and investigation review.
- Genuine curiosity and initiative with a proven track record of handling quality records accurately and efficiently.
skills: Quality Assurance, GMP (Good Manufacturing Practice), Deviation Management, Corrective and Preventive Actions (CAPA), Change Control Management, Quality Assurance (QA)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
