Teva Pharmaceuticals Quality Control Analyst III in Cincinnati, Ohio
Actively participate as a team member supporting the routine and non-routine testing of drug products and raw materials into the QC Laboratory. Analyst will perform analytical bench chemistry according to established compendia and vendor specifications. The ideal candidate will have strong problem solving and analytical capabilities and must be able to work independently to achieve team goals and milestones.
Key Duties and Responsibliities:
Perform analyses and tests of drug products, raw materials, in-process materials, release test samples or stability samples, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance with established specifications
Perform a variety of qualitative tests or qualitative assays on samples using techniques that vary from standard analytical equipment to modern and automated instrumentation.
Utilize electronic laboratory information systems such as LIMS and Empower for acquisition and processing of analytical data
Responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation
Ability to write technical documents (i.e. protocols, reports, change controls, SOPs)
Advanced knowledge of analytical chemistry, chromatography (HPLC/UHPLC) and drug dissolution testing
Serve as a mentor for more junior analysts within the team providing guidance and direction as needed
Broader understanding of other aspects of the business and apply quality principles when reviewing documentation and making decisions/ suggestions
Stays current on new requirements & making associated recommendations that affect area of expertise.
Education and Experience Required:
BS or higher in science related discipline, chemistry is preferred
Minimum 3 years of experience in a pharmaceutical environment
Compliance and Quality:
Thorough knowledge and understanding of USP, cGMP, ICH and FDA guidelines
Use of risk assessment tools within own area using knowledge, managing risk and assessing impact to make decisions
Promote Quality and GMP by analyzing the implications of deviations, and implement solutions under guidance.
Provide feedback on systems and processes to promote continuous improvement and champion selected changes
Grow in the job, accountable for establishing and accomplishing annual personal development goals
Participate in daily direction setting huddles to provide feedback and ensure alignment on daily/weekly/monthly objectives
Actively participate in regular one-on-one meetings with direct supervisor
Troubleshoot problems encountered with methods and instruments - routinely solve, choosing among clearly defined alternatives
Ability to independently solve more complex problems – takes new perspective using existing solutions
Applies root cause problem solving principles for identification and implementation of effective corrective and preventive actions
Requisition # 17-19525
# Positions 1
Experience (Years) 3
Category Quality - Quality Control
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.