Quality Assurance Auditor
Company: Teva Pharmaceuticals
Posted on: December 1, 2019
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
- 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
- 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
- Ensures departmental SOPs are consistent with site, corporate,
and industry standards.
- Oversees the maintenance and update of the department tracking
- 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
- 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
- Initiates Hold Notices, as required.
- Provides copies of documents required for Regulatory
- 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
- 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
- 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
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