Manufacturing Specialist (Quality Records, Trackwise, Veeva)

Aequor; Thousand Oaks (CA); Remote; USD 100,000 - 125,000; Full time

Job summary

A leading company in pharmaceutical manufacturing seeks a Manufacturing Specialist responsible for managing quality records, including deviations and CAPA processes. The ideal candidate will possess a B.S. degree and have 3-5 years of relevant experience in quality management systems. This is a contract position offering remote work flexibility, making it an exciting opportunity to join a dynamic team.

Qualifications

• B.S. + 3-5 years of experience required.
• Quality records experience preferred.
• Experience managing deviations, CAPAs, and change control.

Responsibilities

• Manage quality records related to deviations and CAPAs.
• Monitor and investigate deviations owned by External Supply.
• Build and present quality records summaries for Senior Management.

Skills

Quality records management

Basic project management

Education

B.S. degree

Tools

Trackwise

Veeva

Job description

Manufacturing Specialist (Quality Records, Trackwise, Veeva)

Manufacturing Specialist (Quality Records, Trackwise, Veeva)

15 hours ago Be among the first 25 applicants

This range is provided by Aequor. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$40.00/hr - $45.00/hr

Job Title: Specialist Manufacturing

Location: Thousand Oaks CA – 100% Remote

Duration: 12 Months with Possible extension

Terms: Contract W2

Description:

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 across the network.

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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Manufacturing

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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