Specialist Manufacturing

Advanced Bio-Logic Solutions Corp; Thousand Oaks (CA); Remote; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Specialist Manufacturing to oversee quality records in a remote setting. This role involves managing deviations, CAPAs, and change control processes, ensuring compliance with regulatory standards. The ideal candidate will have a strong background in quality record management, preferably within the biotech sector, and experience with tools like Veeva or Trackwise. This position offers a unique opportunity to drive quality initiatives and collaborate with cross-functional teams, making a significant impact on the organization’s quality management efforts. If you have the passion for quality and a proactive approach, this could be the perfect fit for you.

Qualifications

• Experience managing quality records like deviations and CAPAs is essential.
• Project management skills and biotech industry experience are preferred.

Responsibilities

• Manage and close quality records under the company's quality management system.
• Monitor deviations and implement corrective actions across teams.

Skills

Quality record management

Project management

Biotech industry knowledge

Education

Doctorate degree

Master degree

Bachelor degree

Associate degree

High school diploma / GED

Tools

Veeva Systems

Trackwise

Job description

Description:
Note:
Remote - Any time zone

IDEAL CANDIDATE: B.S. + 3-5 YOE

• Quality records experience working with suppliers would be a home run candidate.
• The ideal candidate should have previous experience managing quality records as owner (such as deviations, change control, supplier investigations, etc.).
• Preferred experience managing in Track Wise or Veeva Systems.
• Basic project management skills required.
• 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.

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 investigates 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.

Basic Qualifications:

• Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience.

Top 3 Must Have Skill Sets:

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

Pay Rate: between $41 - $47/Hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"