Quality Analyst I

Teva Pharmaceuticals • Salt Lake City, UT

20d

About The Position

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.The opportunityThis 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.How you’ll spend your dayAll 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.

Requirements

• Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
• Requires a Bachelor’s degree or equivalent education/experience with a minimum of three years relevant 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.
• 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.
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers, management and external partners.

Nice To Haves

• ASQ Certification preferred.

Responsibilities

• 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 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 is responsible for successfully hitting metrics delivery schedules.
• 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 supporting investigations and process improvement initiatives in the Quality and Production Areas.
• Responsible for supporting ongoing quality and compliance initiatives at the site (i.e. reducing events related to human errors).
• 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.

Benefits

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees