14 days old

Quality Assurance Auditor

Elizabeth, NJ 07201
Company Info

Teva is a global pharmaceutical leader and the worlds largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.  Our employees are at the core of our success, with colleagues in over 80 countries delivering the worlds largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and weve built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.  This is how we improve health and enable people to live better, healthier lives.  Join us on our journey of growth!

 

We offer a competitive benefits package including Medical, Dental, Vision and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance.  

 

For more on Teva, check us out at www.tevapharm.com or www.tevausa.com

 

The QA Auditor supports the site by performing cGMP required Quality Assurance auditing and documentation review functions of production/packaging records, APIs, excipients, packaging components & labeling components for the Elizabeth/Edison sites while following cGMP and corporate policies to achieve company goals and initiatives.

 

Essential Duties / Functions:

  • Audits Manufacturing/Packaging Batch Records at the site.
  • Review and release of APIs, excipients, packaging components and labeling components.
  • Processes materials for release after review of testing/inspection documentation and confirmation that all relevant SOP release requirements have been met.
  • Performs all material release duties and responsibilities in a timely manner. 
  • Interacts with other departments (e.g., Supply Chain, Central Weigh, etc.) to resolve material documentation issues or to address questions relating to material status.
  • Maintains/updates the QAD and WDMS inventory systems with the most current and accurate information relating to material inventory status as a material status changes. 
  • Reviews and approves any requested raw material Certificates of Analysis (CoAs).
  • Ensures departmental SOPs are consistent with site, corporate, and industry standards.
  • Oversees the maintenance and update of the department tracking systems.
  • Audits records to ensure compliance with the approved master formulas and master packaging records.
  • Audits records to ensure compliance with 21CFR Part 211 subpart F (Production and Process Control) and subpart J (Records and Reports).
  • Ensures material compliance with current Good Manufacturing Practices (cGMPs), and Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and other regulatory compliance regulations and standards, as applicable.
  • Identifies the need for investigations for deviations.
  • Develops control documents pertinent to Quality Assurance (QA) activities and functions, as well as other procedures, if deemed necessary.
  • Initiates Hold Notices, as required.
  • Provides copies of documents required for Regulatory filings.
  • Performs additional responsibilities/projects as assigned by area management

Education: 

  • BA/BS Degree preferred. 
  • High School diploma or GED required

 

Experience:

  • 3+ year experience in a Quality Assurance function with a solid dose pharmaceutical manufacturer or packager

 

Specialized/Technical Knowledge:

 

  • Current knowledge of Documentation, Change Control and cGMP's in the pharmaceutical industry.
  • Ability to interact with all levels of the organization.
  • Ability to foster and work in a team environment.
  • Experience using Microsoft Office applications, TrackWise, Qumas, WDMS and QAD.
  • Must be well organized, detail-oriented, and experienced in working with minimal supervision.
  • Must possess excellent verbal and written communication skills.
  • Thorough knowledge of cGMPs.

 

Physical Requirements:

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus

Categories

Posted: 2019-11-26 Expires: 2020-01-08

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Quality Assurance Auditor

Teva Pharmaceuticals
Elizabeth, NJ 07201

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