Teva Pharmaceuticals USA, Inc.

Quality Analyst II

US-UT-Salt Lake City
Requisition #
17-20145
# Positions
1
Experience (Years)
5
Category
Quality - Compliance

Overview

Teva USA, a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd., is a leading global organization employing 26,000 people worldwide. Our aggressive growth strategy has positioned Teva as a top 20 global pharmaceutical company with plans to be Top 10 in the coming years. 

 

We have an opportunity for a Quality Analyst II at our location in the International Center, just west of the Salt Lake City Airport.

Responsibilities

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 in-line inspections for all manufactured batches and issue/review/release raw materials, labeling materials and packaging materials as needed.

 

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 minimal oversight directed at anomalous issues or observations.
  • Responsible for performing activities in support of QA Operational support which may include label issuance, floor support, audit/walkthrough support, AQL assessment, investigation assessment, and training.
  • Responsible for compiling and maintaining metrics and tracking logs at the request of management and successfully hitting metrics delivery schedules.
  • Responsible for writing or reviewing/approving investigations and leading process improvement initiatives in the Quality and Production Areas.
  • Responsible for leading ongoing quality and compliance initiatives at the site (i.e. reducing events related to human errors).
  • Responsible for serving as QA lead on research and development products and related document reviews/approvals – including change control items, protocols, batch records and deviations as applicable and product disposition.
  • Responsible for providing training and guidance to others within QA and other departments as needed.
  • 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.

Qualifications

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

 

Education/Certification/Experience:

  • Requires a Bachelor’s degree or equivalent education/experience with a minimum of three to five years relevant QA experience in a manufacturing environment within pharmaceutical, medical device, nutraceutical, or food processing industries preferred.
  • Requires working knowledge of cGMP, DEA and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
  • ASQ Certification preferred.

Skills/Knowledge/Abilities:

  • Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP system such as SAP or Oracle and manufacturing/quality systems such as Trackwise and Qdocs.
  • Self-directed with ability to organize and prioritize work with little instruction on routine work and under general instructions on new projects.
  • Ability to communicate effectively with excellent written and oral communication skills.
  • Ability to interact positively and collaborate with co-workers, management and external partners.
  • Motivate and influence others without direct authority.
  • Detail oriented with ability to identify errors or inconsistencies while performing tasks and to solicit or initiate corrective responses.

 Problem Solving:

  • Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
  • Seeks out all resources when selecting methods and techniques for obtaining results.
  • Acts independently and proactively to recommend and administer methods and procedures for problem resolution.

PHYSICAL REQUIREMENTS:

 

Frequent:

  • Fingering – using fingers such as picking, pinching or typing.
  • Repetitive Motions – frequent motions of the wrists, hands and/or fingers.
  • Sitting for extended periods of time.

 Occasional:

  • Standing for extended periods of time at work station or equipment
  • Walking to move short distances quickly and frequently.
  • Grasping – applying pressure to an object with the fingers and palm
  • Lifting – raising objects from lower to upper and/or moving objects horizontally – up to 25 lbs.

Visual Acuity: 

  • Perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.

WORKING ENVIRONMENT:

  • Occasional exposure to moderate to loud noise levels.
  • Occasional exposure to moving mechanical parts or equipment.
  • Occasional exposure to fumes, odors, dusts, mists, gasses or vibrations.
  • May be required to wear personal protective equipment (PPE) as needed when in production areas (i.e. safety glasses, respirator, hearing protection, gloves, etc.).

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