Teva Pharmaceuticals Quality Senior Specialist (Monday-Thursday, 3pm-1:30am) in Salt Lake City, Utah
Quality Senior Specialist (Monday-Thursday, 3pm-1:30am)
Date: Apr 8, 2021
Location: Salt Lake City, Utah, US, 84116
Company: Teva Pharmaceuticals
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!
Teva Pharmaceuticals is looking to fill a Quality Senior Specialist in Salt Lake City, Utah. This position is responsible for monitoring production operations through the use of multiple mechanisms including routine line checks, line clearance activities, in-process inspection oversight, 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. This position is responsible for ensuring all site and regulatory requirements are satisfied for raw materials, labeling materials, and packaging materials prior to release. This position is responsible for artwork review and approval, retain management and label issuance as needed to support operations.
Shift: Monday-Thursday, 3pm-1:30am
Job Responsibilities & Duties:
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 collecting, assembling, and managing information and making appropriate decisions on approval or rejection for all components, drug product containers, in-process materials, packaging materials, labeling, and drug products manufactured.
• Responsible for conducting Foreign Matter Investigations as needed for materials throughout the lifecycle of the receipt, sampling, testing, dispensing and other in-process stages of material use.
• Responsible for receipt, log in and management of incoming retains and in-house retains. This includes management of annual inventory, annual product reviews and destruction of materials which have exceeded expiry.
• Responsible for serving as a QA “first responder” for various issues that occur on the manufacturing/ packaging floor and/or during batch record documentation/review and providing directions for situations of low complexity; moderate to high complexity situations must be deferred to more senior QA personnel.
• Responsible for labeling issuance, review and/or returns; document processing including data entry, data verification and/or processing/controls of documentation.
• Responsible for participating in investigations and providing recommendations for corrective actions and prevention of recurrence.
• Responsible for writing, 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 such as artwork, raw material files, AQL inspection forms, and labeling.
• Responsible for performing additional related duties as assigned.
• Requires High School Diploma or equivalent.
• Minimum of 1 year of experience in a regulated environment required; pharmaceutical, medical device, nutraceutical, or food processing industry experience is preferred.
• 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 is preferred.
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle and manufacturing/quality systems such as LIMS, Trackwise and Qdocs.
• Self-directed with ability to organize and prioritize work.
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers, management and external partners.
Manufacturing Quality Assurance
In process of validation
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Teva’s 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.
We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
EOE including disability/veteran