Manufacturing Specialist

Duration: 6 months contract

Shift: 8AM-5PM Mon-Fri (onsite 3 days a week, remote the rest of the time)

Job Description:

Quality professional to support external-facing quality records related to raw material suppliers. 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.
• 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.

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.

Basic Qualifications:

• Doctorate degree OR
• Masters degree and 2 years of experience OR
• Bachelors degree and 4 years of experience OR
• Associates degree and 8 years of experience OR
• High school diploma / GED and 10 years of experience

Top 3 must have skills:

• Quality record owner experience (I.e. Deviations, Supplier investigations, CAPA, and Change Control)
• Basic knowledge of Veeva or Trackwise
• Biotech industry experience

Day to Day Responsibilities:

• Quality record ownership and documentation.
• Schedule and lead follow up meetings with cross functional partners and suppliers.
• Engage in meaningful assessments on root cause analysis and evaluation of defect materials.
• Routine visits to the New Albany, OH site.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"

Thanks and Regards,

Bilal Ahmed

Email: bilal.ahmed@ustechsolutionsinc.com

Internal Job ID: 25-53019