Address
Form of workWho 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 II- QA On-the-Floor (OTF) is responsible for performing QA OTF activities, in order to support biologics manufacturing of cell bank, bulk drug substance, drug product, and placebo.
Essential Responsibilities:
• Provide QA support on the manufacturing floor during critical activities for cell bank, bulk drug substance, drug product, and placebo
• Provide QA support on the manufacturing floor during media fills
• Ensure manufacturing activities are performed and document using current Good Manufacturing Practices
• Participate in internal technology transfer meetings
• Review and approve product and solution master batch records (PRCs)
• Perform product changeover
• Review and approve SOPs, work instructions, and controlled forms
• Utilize Quality Systems to review and approve change controls, deviations, CAPAs and CAPA effectiveness checks
• Use of SAP, Trackwise, TevaDoc, LIMS, and TevaLMS to execute GMP QA activities as applicable
• Support regulatory agency filings, inspections, and internal audits, as needed
Qualifications:
Enjoy a more rewarding choice
Make a difference with Teva Pharmaceuticals
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.
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.
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 II- QA On-the-Floor (OTF) is responsible for performing QA OTF activities, in order to support biologics manufacturing of cell bank, bulk drug substance, drug product, and placebo.
Essential Responsibilities:
• Provide QA support on the manufacturing floor during critical activities for cell bank, bulk drug substance, drug product, and placebo
• Provide QA support on the manufacturing floor during media fills
• Ensure manufacturing activities are performed and document using current Good Manufacturing Practices
• Participate in internal technology transfer meetings
• Review and approve product and solution master batch records (PRCs)
• Perform product changeover
• Review and approve SOPs, work instructions, and controlled forms
• Utilize Quality Systems to review and approve change controls, deviations, CAPAs and CAPA effectiveness checks
• Use of SAP, Trackwise, TevaDoc, LIMS, and TevaLMS to execute GMP QA activities as applicable
• Support regulatory agency filings, inspections, and internal audits, as needed
Qualifications:
- BS/BA or Undergraduate degree in applicable disciple preferably life science.
- Knowledge in Quality Compliance (cGMP, ICH, FDA, EMA, USP/EP policies & guidelines) required.
- Minimum 2 years QA experience in development of Biopharmaceutical/Biologics/Large Molecule products, or equivalent.
- Experienced in biopharmaceutical operations and cGMP documentation practices.
- Basic experience with SAP, Trackwise, EDMS, CMMS preferred.
- Good oral and writing communication skills.
- Cooperative, multi-tasking, detail oriented, and strong organizational skills.
- Proficient with Microsoft Word and Excel.
Enjoy a more rewarding choice
Make a difference with Teva Pharmaceuticals
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.
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.
