Who we are 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 opportunity

Under minimum supervision, ensures compliance to cGMP regulations in manufacturing area including all documentation complying with the Company's Standard Operating Procedures (SOP's), governmental regulations and other requirements where applicable.  Facilitates communication between departments to ensure a smooth flow of materials and release.  Perform batch record review of intermediate and finished materials.  Perform release of intermediate materials. 

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. This role requires knowledge and experience in own discipline; still acquiring higher level knowledge and skills. Build knowledge of the organization, processes, and customers. Solve a range of straightforward problems. Analyzes possible solutions using standard procedures. Receives low to moderate level of guidance and direction. Any non-essential functions are assumed to be included in other related duties or assignments.   

Carries out lead responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.  Assists in the training of new auditors in job duties according to Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and Company training procedures.  Perform review of intermediate and finished material batch records.  Interface with manufacturing, warehouse, and QC materials management to ensure timely and accurate shipment of materials and products.  Audit data from Quality Control, vendor's certificate of analysis, and other related documentation of products and materials.  Prepare, revise and verify SOP, Sampling Plans, MPRs, Swab Data, and BMS system data.  Maintain Quality Assurance documentation files, databases, and logs.  Assist in preparing budgets and reviews.  Conduct final audit of Laboratory Service Reports for in-process and finished product reports, assuring compliance with cGMPs, current Good Laboratory Procedures (cGLPs), test methods and SOPs and prepare documentation for release.  Conduct audits of other documents as directed by the Supervisor and prepare these documents for release, assuring compliance with cGMPs and SOPs.  Interface with other department's personnel to complete job duties.  Participates in and provides training programs for the development of successful working understanding of materials presented and become more proficient in assigned duties and tasks.  Provides support, direction, and coaching to team members in the areas of training, problem resolution, planning, and work assignment delegation.  Ensures project deadlines and performance standards are established and met.  Ensures compliance with all company policies and procedures, including safety rules and regulations.  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: 

Bachelor's Degree in Science or related field from an accredited college or university, and three (3) years pharmaceutical quality assurance auditing experience.  An equivalent combination of education and experience may be substituted. 

Skills: 

Observing and identifying problems, assisting in resolution to support Company goals.  Reading, interpreting records, reports, business, personal and scientific computer data, certificates of analysis and conformance and other applicable data sources  Responding to inquiries from management, employees and regulatory agencies under direction of management.  Communicating clearly and concisely, both orally and in writing.  Operating scientific, business and personal computers.  Applying Federal, state and local policies, procedures and regulations.  Establishing and maintaining cooperative working relationships with others. 

Knowledge/Abilities: 

Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.  Advanced principles of auditing.  AQL sampling and inspection principles and techniques.  Principles of mathematical and statistical computation and analysis.  Business, scientific and personal computer hardware and software applications.  Pharmaceutical principles, practices and their applications.  Leadership and training methods and techniques. 

TRAVEL REQUIREMENTS : N/A 

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

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.

Important notice to Employment Agencies - Please Read Carefully

Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities.  All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.