ElizabethRecruiter Since 2001
the smart solution for Elizabeth jobs

Quality Assurance Auditor

Company: Teva Pharmaceuticals
Location: Elizabeth
Posted on: December 1, 2019

Job Description:

Quality Assurance AuditorDate: Nov 26, 2019Location: Elizabeth, New Jersey, US, 07202Company: Teva PharmaceuticalsCompany 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.comJob Description 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 managementQualifications Education:
    • BA/BS Degree preferred.
    • High School diploma or GED requiredExperience:
      • 3+ year experience in a Quality Assurance function with a solid dose pharmaceutical manufacturer or packagerSpecialized/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 focusFunction QualitySub Function Quality Assurance MethodsReports To Senior Manager Quality AssuranceAlready Working @TEVA? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career SiteThe internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.Tevas Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.EOE including disability/veteran

Keywords: Teva Pharmaceuticals, Elizabeth , Quality Assurance Auditor, Accounting, Auditing , Elizabeth, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Accounting, Auditing Jobs

Senior Financial Analyst - Everyday Health What to Expect
Description: Description Position at Everyday Health Everyday Health is seeking a Senior Financial Analyst to join our team. We are looking for someone who has the ability to work with large amounts of information, (more...)
Company: j2 Global Communications, Inc.
Location: New York
Posted on: 12/10/2019

Finance, Controllers, Controllers Modeling, Associate, New York
Description: br br FINANCE br br The Goldman Sachs Group, Inc. is a leading global financial services firm providing investment banking, securities and investment management services to a substantial and (more...)
Company: Goldman Sachs
Location: New York
Posted on: 12/10/2019

Junior Accountant
Description: Company SummaryHelix is an innovative direct-to-consumer sleep brand aiming to change the way people sleep by bringing customization to the sleep category through individually personalized mattresses (more...)
Company: Helix Sleep
Location: New York
Posted on: 12/10/2019

Tax Services - Merger and Acquisition Tax - Director
Description: A career in our Merger and Acquisition Tax practice, within Tax services, will provide you with the opportunity to help our clients meet and manage their tax obligations across unique but ever changing (more...)
Company: PwC
Location: New York
Posted on: 12/10/2019

Treasury Operations Specialist
Description: Treasury Operations AnalystSummary:Follows established guidelines for day-to-day, routine operational and administrative work. May be required to
Company: Top Int'l Banking Institution
Location: New York
Posted on: 12/10/2019

Senior Manager, Partner and Product Implementation
Description: How will this role have an impact Yes. This role will lead the planning and implementation of strategic initiatives spanning the organization that directly impact Remedy's provider partners across the (more...)
Company: Remedy Partners
Location: New York
Posted on: 12/10/2019

Part-Time Accounting Administrator
Description: Rapidly growing Flooring Installation Service Company is seeking a high energy, motivated individual to join our Accounting Department on a part-time
Company: ACS
Location: Passaic
Posted on: 12/10/2019

Accounts payable/Billing specialist
Description: HLW is an organization of architects, interior designers, workplace strategists and thought leaders working with vibrant global organizations. Our offices in New York, New Jersey, Los Angeles, London (more...)
Company: HLW International LLP
Location: New York
Posted on: 12/10/2019

Senior Consolidations Accountant
Description: Job Description SummaryJob DescriptionReporting to the Consolidations Manager in the Corporate Controllers Group, the Senior Consolidations Accountant is responsible for the consolidation and preparation (more...)
Company: Becton Dickinson & Company
Location: Franklin Lakes
Posted on: 12/10/2019

Financial Advisor
Description: Opportunity OverviewStart a brand new career with support and flexibility. Were looking for professionals with a track record of success to join our growing financial services firm. Ambitious people who (more...)
Company: Edward Jones
Location: Paterson
Posted on: 12/10/2019

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

Elizabeth RSS job feeds