Quality Analyst Iii - Analytical Lab Support

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
The Quality Analyst III possesses the compliance and Regulatory knowledge and skills necessary to provide direction and guidance in current Good Manufacturing Practice (cGMP) regulations for commercial and clinical biopharmaceutical manufacturing. The Quality Analyst III works to assure the quality, accuracy, and integrity of data in manufacturing operations, and regulatory submissions and to assure that effective and appropriate Quality Management Systems are followed. They will apply their experience and excellent communication skills within a collaborative environment to assure that the GMP Quality culture are embraced by the site to enable a commitment to continuous quality improvement and embrace a permanent inspection ready attitude. Specific areas of responsibility include Quality Assurance oversight and support of GMP Analytical Laboratories.
This is not a remote position.
How you'll spend your day

• Provide QA support of Quality Control GMP activities.
• Ensure activities are performed/completed using current Good Manufacturing Practices.
• Hands on experience in analytical test methods, assays and/or compendia methods, and knowledge of related analytical equipment/software.
• Review of analytical testing data for accuracy/completeness/cGMP documentation.
• Serve as Quality resource, representing QA on teams in support of assignments.
• Provide feed-back/communication of any issues.
• Review and approve analytical method validation protocols, method transfer protocols, stability protocols, and technical reports.
• Review and approve SOPs, work instructions, and controlled forms.
• Utilize Quality Systems to review and approve change controls, deviations, laboratory investigations, CAPAs and CAPA Effectiveness checks.
• Participate/support regulatory agency filings, inspections, and internal audits, as needed.

Additional Responsibilities, as needed / Preferred Experience

• Assess manufacturing activities for proper aseptic techniques.
• Possess strong understanding of gowning and aseptic techniques for controlled/classified environments.
• Review of production records ensuring quality and proper cGMP documentation.
• Perform material disposition and release.
• Perform area clearances/releases in accordance with standard operating procedures.

Your experience and qualifications

• BS/BA or Undergraduate degree in applicable disciple preferably life science.
• Minimum 5 years QA experience in development of Biopharmaceutical/Biologics/Large Molecule products, or equivalent.
• Knowledge in Quality Compliance (cGMP/ICHIFDAIUSP/EP policies/guidelines) required.
• Experience in development of Biopharmaceutical/Biologics/Large Molecule products preferred.
• Proficient with Microsoft Word and Excel.
• Familiar with biopharmaceutical operations and cGMP documentation practices.
• Experience with LIMS and TrackWise a plus.

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.