Quality Assurance Auditor I

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

This position is responsible for leading and maintaining the site Internal Audit Program and providing support during business partner audits and regulatory inspections.  This position supports teams using trend and investigational data to create value through process improvements and failure reduction activities and provides representation for quality department on cross functional teams.  In addition, provide support to monthly quality metrics, Site Quality Council, Compliance Gap Assessments, Inspection Readiness, Deviations, CAPAs, Complaints and other miscellaneous quality projects.

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. 

•    Compliance with Internal Audit Program schedule
•    Generate, Collect and Upload Monthly & Quarterly Metrics for Quality Council and Site Quality Risk Map
•    Prepare supporting documentation, facilitate and attend the Site Quality Council, present area results and prepare meeting minutes
•    Prepare Site Quality Councils presentation on time
•    Provide High quality support for Compliance CAPAs and investigations. Help develop and conduct the site Internal Audit Program.
•    Provide support during Teva’s GRA Audits, Third Party Audits and outside Regulatory Inspections (e.g. FDA, MHRA, EU, Anvisa, etc.).
•    Provide support to Site Inspection Readiness activities.
•    Support Complaint investigations
•    Assign, monitor and close audit and Compliance CAPAs in the Quality System.
•    Perform gap assessments to ensure compliance with regulations.
•    Provide support for site investigations.
•    Prepares and submits reports, standards, and other documents as required.
•    Engage in and promote Quality & Operational Excellence.
•    Coordinate with other departments and perform investigations, and process change controls.
•    Prepare APR contributions for complaints, investigations to show product performance and determine compliance
•    Coordinate with other departments to complete investigations and reports
•    Review and approve protocols, reports and change controls
•    Provide guidance and coaching to employees on GMP, inspection readiness and quality systems
•    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, procedures, state, federal and local laws, Good Manufacturing Practices (cGMP’s), and Standard Operating Procedures (SOP’s) instructions. 
•    Responsible for performing additional related duties as assigned or required by business needs. 
 

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 Bachelor’s Degree in Science, Engineering or related field from an accredited college or university.
•    Minimum of five years relevant progressive QA experience in the pharmaceutical or a related industry or an equivalent combination of education and experience
•    Requires experience in a solid dose manufacturing environment.
•    Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
•    Requires experience with the handling of deviations, investigations, and CAPA's.
•    Experience with Manufacturing/Quality systems such as TrackWise, Glorya, Veeva, LIMS/Labware, SAP, Learning Management Systems and statistical software preferred.
•    Knowledge of CGMPs, SOPs, FDA, and other regulatory compliance regulations and standards required
•    ASQ/CQE/CQA Certification preferred.

Skills/Knowledge/Abilities:
•    Strong Project Management and organizational skills.
•    Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and or/techniques for resolutions.
•    Responding to technical inquiries from management, peers, and regulatory agencies.
•    Operating scientific and personal computers.
•    Managing multiple projects, duties, and assignments.
•    Interpreting and applying Federal, state, and local policies, procedures and regulations.
•    Establishing and maintaining cooperative working relationships with others.
•    Pharmaceutical principles, practices, and their application.
•    FDA, SOP, cGMP and other pertinent regulatory compliance and requirements.
•    Pertinent Federal and State laws related to personnel administration.
•    Business English usage, spelling, grammar, and punctuation.
•    Principles of safety, worker’s compensation, OSHA, and related principles and practices.
•    Business, scientific and personal computer hardware and software applications.
•    Skill levels in MS Office including proficiency in Word, PowerPoint, Excel, Teams and SharePoint.  
•    Must be able to maintain the highest levels of confidentiality, integrity and discretion. 
•    Excellent verbal, written, and interpersonal skills required. 

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.
•    Acts independently and proactively to recommend and administer methods and procedures for problem resolution.
•    Able to identify solutions to general problems through collaboration and creativity.

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.