Overview
Reviews laboratory testing data/records in accordance with current Good Manufacturing Practices (cGMP), and Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies, as applicable. Monitor processes for adherence to establishedprocedures/regulatory compliance. Provides guidance for quality related issues and consults with QA Management to resolve complex quality issues in a timely manner. Updates Standard Operating Procedure(s) and performs training.
Responsibilities
- Stay current with changes to GXP, including FDA and EU and other regulatorybodies as well as guidance documents (e.g.,: ICH, ISPE, etc.)
- Compiles and reviews raw data, testing records and results in accordance to cGMPand internal procedures in an efficient and timely manner. Assure that anyobservations/deviations are properly investigated and explained.
- Compiles and reviews raw data, batch records and test results, including FinalReports in accordance with cGMP, GLP, Code of Federal Regulations (CFR), Pointsto Consider (PTC) guidelines and internal procedures in an efficient and timelymanner. Assure that any observations/deviations are properly investigated andexplained.
- Perform timely review of complex study files, such as: Assay Validations,Qualifications, Viral Clearance.
- Reviews and approves Deviation reports.
- Perform QA inspections including, but not limited to GLP studies.
- Review and approve document change requests.
- Perform review and approval of Laboratory Investigations (OOS) and Nonconformingevents.
- Write nonconforming events or deviations if necessary.
- Participate as needed to support internal and/or client audits.
- Write and revise SOPs as necessary.
- Perform trend analysis and report results for quality metrics.
- Assists Management in the training of new hires.
- Participate in quality and process improvement initiatives, and project teams.
- Works on routine assignments per written procedures, where ability to recognizedeviation from accepted practice is required.
- Normally receives minimal instructions on routine work and detailed instructions onnew assignments.
Qualifications
- At least 2 years of relevant laboratory and/or QA experience or equivalent.
- Bachelors’ degree in a Science related field.
Knowledge / Skills / Abilities:
- Knowledge of GLP and cGMP requirements, PTC guidelines and ISO17205 ishighly desirable.
- Ability to accomplish the described duties through the use of appropriate computerequipment and software (Microsoft Word, Excel, Outlook, and Access).
- Ability to accurately and reproducibly perform arithmetic, algebraic and geometriccalculations.
- Ability to record data accurately and legibly.
- Ability to use judgment as dictated by the complexity of the situation.
- Ability to understand and follow verbal or demonstrated instructions.
- Ability to work effectively as part of a team and to exhibit effective interpersonalskills.
- Ability to receive, comprehend and to effectively communicate detailedinformation through verbal and written communication.
- Proficient in Oral & Written communication skills.
Our Values:
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
Horsham, Pennsylvania
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