Quality Sr Specialist - SLC West
Teva PharmaceuticalsAbout the role
Who we are
If you’re like people at Teva, you dare to be different. We’re making well-being a way of life for our customers and our colleagues. Join us in helping to make healthcare more accessible to more patients, while supporting one of the most innovative teams in the industry.
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!
The opportunity
This position is primarily responsible for the review of batch record files and final product release for shipment to end customer and to participate in investigations and trending of quality issues as appropriate. Additionally, this position will support QA Production Operations for all manufactured batches and issue/review/release raw materials, labeling materials and packaging materials as needed and for providing general guidance and instruction to correct identified deficiencies during documentation reviews and other oversight as needed to ensure compliance with company procedures and domestic and international regulatory requirements.
*Please be aware that there are 2 SLC locations. This position is for the West location.
4710 Wiley Post Way
Salt Lake City, UT 84116
How you’ll spend your day
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
- Responsible for conducting review and release activities associated with product and material release with some oversight, but minimal and directed at anomalous issues or observations.
- Responsible for performing activities in support of QA Production Operations support which may include label issuance, floor support, audit/walkthrough support, AQL assessment, and some limited training.
- Responsible for supporting process improvement initiatives in the Quality and Production Areas.
- Responsible for revising or reviewing Standard Operating Procedures (SOP’s), forms and/or Work Instructions with changes of low complexity and responsible for ensuring accuracy and GMP compliance in documents that are being reviewed.
- Responsible for reviewing and approving edits to Master Batch Records submitted for revision and for ensuring accuracy and GMP compliance in documents that are being reviewed.
- Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
- Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
- Responsible for performing additional related duties as assigned.
- May be responsible for maintaining tracking logs as requested and is responsible for successfully meeting metrics delivery schedules.
- May be responsible for providing team member support and participation with ongoing site quality initiatives.
Your experience and qualifications
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience:
- Requires High School Diploma or equivalent.
- Requires a minimum of one year experience in a regulated environment such as pharmaceutical, medical device, nutraceutical, or food processing industries.
- Requires basic understanding of Good Manufacturing Practice (cGMP) and the application to a production environment.
- Associates Degree or higher (or equivalent) achieved or in process preferred.
- ASQ Certification preferred.
Enjoy a more rewarding choice
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,
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