Quality Analyst I

Who we are

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 support Production Operations for all manufactured batches and issue/review/release manufactured materials. Additionally responsible for providing general guidance and instruction to correct identified deficiencies during production walkthroughs and documentation reviews and other oversight as needed to ensure compliance with company procedures and domestic and international regulatory requirements.

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 manufactured product release with some oversight, but minimal and directed at anomalous issues or observations.

· Responsible for performing activities to support Production Operations which includes 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 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 as well as supporting ongoing quality and compliance initiatives at the site including support of Lean Management initiatives (TLMS) (i.e. reducing events or documentation related to human errors).

· 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 completing all training requirements and maintaining 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.

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 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.

· ASQ Certification preferred but not required.

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 management systems such as TrackWise, Veeva and Glorya.

· Self-directed with ability to organize and prioritize work with ability to independently determine prioritization needs and demonstrate flexibility to adjust to changing priorities.

· Ability to communicate effectively with excellent written and oral communication skills.

· Ability to interact positively and collaborate with co-workers, management and external partners.

Problem Solving:

· Works on problems of moderate scope where evaluation of contributing factors requires analysis of situation or data.

· Exercises judgment within broadly defined practices and policies and selects methods and techniques for obtaining solutions.

· Selects methods, techniques, and evaluation criteria for obtaining results.

· Acts independently and proactively to recommend methods and procedures for problem resolution.

Enjoy a more rewarding choice

We offer a competitive benefits package, including: 

• 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.  

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.   

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.

Teva’s Equal Employment Opportunity Commitment