AddressWho we are
The opportunity
This position is responsible for providing Quality Assurance support to Manufacturing, Supply Chain and Quality Control Laboratories by providing QA review and approval of new and existing methods/procedures, validation/transfer protocols, investigation documentation, and process/facility change control documents. This position leads teams using trend and investigational data to create value through process improvements and failure reduction activities, provides representation for quality management and also serves as back up for the Manager, Quality Assurance when required.
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 providing a thorough and timely review and approval of cGMP documents and processes such as those related to deviations, investigations, equipment and facilities maintenance and calibration, protocols and reports, and facility controls, instruments, and procedures.
- Responsible for working with operating departments to facilitate process improvements and lean concepts.
- Responsible for leading cross functional improvement and process monitoring teams to mitigate unfavorable trends.
- Responsible for providing first response and ongoing QA presence for quality and compliance issues on the manufacturing floor and as needed in the laboratories.
- 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 investigating critical events, supporting other quality team members in the analysis and documentation.
- Responsible for working with the laboratory to investigate OOT and OOS events, providing feedback and manufacturing information.
- Responsible for compiling and maintaining metrics and tracking logs for site’s quality KPI’s or other functions.
- Responsible for supporting internal/external, scheduled and unscheduled audits of operational areas.
- Responsible for supporting activities within electronic systems as needed, such as LIMS, TrackWise, EAM.
- Responsible for serving as QA backup as final review/release of production batch records.
- Responsible for serving as QA backup for managing the site change control system.
- Responsible for serving as QA backup on validation/qualification protocols and related document reviews/approvals along with providing Quality Engineering support for change control items, protocols, batch records and deviations as applicable and product disposition.
- 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.
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 with a minimum of 10 years relevant progressive QA experience in the pharmaceutical or a related industry.
- Prefer degree in Science or Engineering.
- Preferred 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.
- Requires experience with managing partner relationships.
- Experience with Manufacturing/Quality systems such as Trackwise, LIMS/Labware, Crystal Reports, Learning Management Systems and statistical software preferred.
- Experience with laboratory related investigations/inquiries preferred.
- ASQ/CQE/CQA Certification preferred.
Skills/Knowledge/Abilities:
- Detail oriented with ability to analyze information and create corresponding performance metrics.
- Computer proficiency with comprehensive working knowledge of MS Office products and computer relational databases.
- Ability to demonstrate sound judgment and decision making.
- Ability to build and maintain collaborative relationships between teams, departments and business units.
- Motivate, influence and lead others with and/or without direct supervisory authority.
- Communicate effectively with excellent written and oral communication skills.
- Interact positively and collaborate with co-workers, management and external partners.
- Manage conflict and negotiate resolution.
- Self-directed with ability to organize and prioritize work.
- Project management and advanced presentation skills preferred.
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.
Enjoy a more rewarding choice
We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.
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.
This position is not eligible for sponsorship. To be considered for this opportunity, you must apply on our career page.
