5 days old

Quality Assurance Retention Sample Coordinator

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Company Info
Teva is a global pharmaceutical leader and the world's 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 world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've 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!
Job Description

Responsible for the receipt, storage, and management of finished product retention samples, performance of annual physical evaluation of retention samples per CFR 211.170, as well as retention sample inspections to support customer complaint and deviation investigations, ensuring compliance with cGMPs, site policies, and procedures.


Essential Duties / Functions:
 Responsible for the receipt, log in, storage, and management of finished product retention samples.
 Performs annual physical evaluation of retention samples
 Performs inspection of retention samples to support customer complaint and deviation investigations
 Conducts semi-annual and annual inventory of DEA retention samples
 Performs DEA and non-DEA retention sample destruction activities.
 Performs monthly archival of expired retain samples.
 Submits samples to the Quality Control and Stability departments for testing.
 Assists in performing Quality Monitoring functions of all required areas.
 Assesses the adequacy of packaging batch record documentation on-line.
 Audits records to ensure compliance with 21CFR Part 211 subpart F (Production and Process Control) and subpart J (Records and Reports).
 Assists in Annual Product Reviews and Customer Complaints by providing data and inspection results.
 May assist in the release of bulk products for Packaging.
 May assist in the issuance of Hold Notices in Trackwise and material Variance Notices.
 Maintains documentation of all activities.
 May perform GMP Housekeeping Inspections.
 May perform production area audits and checks, ANSI inspections, and general inspections.
 Primary location is Edison; ability to be flexible to work at the Elizabeth site when needed.
 Performs additional responsibilities/projects as assigned by area management.

Qualifications


Education Required:
High School diploma or GED required

 

Expreience Required:
3-5 years experience in a relevant Quality Assurance environment

 

Specialized or Technical Knowledge, Licenses, Certifications required:
 Certified Quality Inspector (ASQ or equivalent) preferred
 Thorough knowledge of cGMPs in the pharmaceutical industry.
 Must be well organized, detail-oriented, have good documentation skills, and experienced in working with minimal supervision.
 Must possess excellent verbal and written communication skills (reads, speaks, and writes English).
 Experience using Microsoft Office applications, including Word and Excel; data entry experience is a plus.
 Must have the ability and willingness to interact and work with various individuals at all levels in the organization.
 Strong mathematical skills
 Understands temperature and weight measures.
 Must have experience using gauges, including, but not limited to, micrometers.
 Must work safely at all times, and comply with all safety policies and procedures.
 Must demonstrate proficient PC skills.
Equipment and Applications
 Microsoft Applications
 Trackwise
 Qumas
 QAD
 File on Q
 Torque Tester
 Scales/Balance
 Weight Variation Machine

 

Physical Demand 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.

Function
Quality
Sub Function
Quality Assurance Methods
Reports To

Senior Manager QA

Already 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 Site

The 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.

Posted: 2020-02-15 Expires: 2020-03-18

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 Retention Sample Coordinator

Teva Pharmaceuticals

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