Quality Analyst II
US - PA - North Wales
Main Job Tasks and Responsibilities
Assure ongoing compliance with quality and industry regulatory requirements for cGMPs, 21CFR 210/211, 21CFR 820 and 21CFR Part 4.
Responsible for release of product manufactured and/or packaged at Teva’s Third Party Suppliers located in the U.S.
Review Quality Customer Complaint investigations, non-conformance reports and Laboratory Investigations ensuring all necessary components are included.
Develop, recommend and monitor corrective and preventive actions (CAPA) and CAPA effectiveness reviews within the TrackWise system.
Evaluate Third Party Supplier Annual product Reviews (APRs) against internal SOPs to identify trends and ensure a continued high level of quality.
Review, evaluate and approve change controls from Third Party Suppliers and act as the point of contact for all comments between internal departments and the site.
Communicate to management critical issues that may impact product on the market or product intended for the commercial market.
Review validation protocols and reports for activities occurring at Third Party Suppliers.
Represent the TPO Quality department and act as the primary contact for various cross functional teams involving product transfers, new product launches, supply chain activities, etc.
Education and Experience
Bachelor’s degree with a minimum of (1) year experience in a Pharmaceutical FDA regulated industry in Quality Assurance or related field.
Must have working knowledge of cGMPs, CFR, ICH and applicable international regulations/guidelines.
Experience with Investigations, Change Controls, Product Release, CAPA, Validations, preferred.
Experience with external pharmaceutical manufacturing, packaging, testing or devices is desired.
Strong computer skills including TrackWise, Oracle and SAP is desired.
Quality: attention to detail and accuracy, committed to excellence, suggests improvements to existing process, identifies root causes, owns and acts on quality issues.
Teamwork: meets all team deadlines and responsibilities, listens and values other’s opinions.
Customer Focus: represents Teva in a professional and positive manner. Sets expectations of quality, solicits opinions and ideas and responds to customer quality inquiries.
Adaptability/flexibility: adjusts plans to meet changing needs, open to new ideas, takes on new responsibilities.
Communicate well both verbally and written.
Collect, manage and analyze data.
Analyze and solve problems using existing solutions.
Plan, prioritize and organize with minimal management oversight.