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Quality Analyst III - 6003

Quality Analyst III - 6003
Date: Oct 3, 2018
Location: Forest, Virginia, US, 24551
Company: Teva Pharmaceutical Industries Ltd.
Company Info
Teva is a global pharmaceutical leader and the world?s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.
Our employees are at the core of our success, with colleagues in over 80 countries delivering the world?s largest medicine cabinet to 200 million people every day.
We offer a uniquely diverse portfolio of products and solutions for patients and we?ve built a promising pipeline centered around our core therapeutic areas.
We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.
This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
Job Description
This Quality Engineer (QE II) position is responsible for providing Quality Assurance support to the third party biological manufacturing facility and internal Adeno Quality needs. The role provides QA review/approval of new/existing technical documents, such as change controls, investigations, batch record review/release, testing methods/procedures, etc, using good documentation practices and compliance procedures. Furthermore, serves as the back-up for the Associate Director, Biologics Quality.
Interacts closely with third party supplier, Regulatory Affairs, QA/QC/Operations to support review, release and technical aspects of biological vaccine production. The following activities are performed based on experience, background and education.
Qualifications
Education/Certification/Experience:
+ A Bachelor?s of Science degree in scientific field with preferred focus on cellular/microbiology/biology with a suggested minimum of 5-10 years of professional experience in a pharmaceutical industry or equivalent combination of training and experience. Experience in aseptic processing and compliance is preferred.
Skills/Knowledge/Abilities:
+ Knowledge of biologic subject matter, cellular biology/microbiology tests, aseptic techniques
+ Basic knowledge of cGMPs, GLP, FDA guidelines, USP and EP and applicable regulatory requirements
+ Reading, understanding and compliance to company policies/procedures
+ Excellent written and verbal communication skills, basic computer skills and data entry
+ Detail oriented, team player with strong interpersonal skills
+ Proven ability to work independently with minimal input from management, set priorities, schedule, execute and complete projects to meet deadlines
Primary Activities:
+ Biologic License Approval (BLA) and post marketing license management
+ RA Support for third party supplier
+ Quality Overview and technical support to the supplier (API)
+ Batch Disposition ? API ? (supplier)
+ Batch Record Review and associated technical documents (from the supplier)
+ Deviation, LIR, CAPA and CC support (from the supplier)
+ CV review/approval
+ Equipment Qualification review/approval
+ Process Validation review/approval
+ Notifications to Management/BPDR ? support as needed
+ Quality Customer Support ? QTA?s (API), etc
+ Supplier Management
+ Quality Shipments and logistics
+ R&D Support as needed
+ Support Production, Validation, and Quality Assurance needs
+ Follow Teva Safety, Health and Environmental policies and procedures Secondary Activities :
+ Batch Disposition ? finished product ? back-up
+ Internal Deviation, LIR, CAPA and CC review/approval ? back-up
+ Trending and various assessments/reports as requiredThe QE II receives minimal supervision for most assignments while working with the Assoc Director and other departments as needed.
Function
Quality
Sub Function
Manufacturing Quality Assurance
Reports To
Associate Director - Biologics Quality
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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
Nearest Major Market: Lynchburg
Nearest Secondary Market: Virginia


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