WuXi AppTec

Quality Assurance Specialist (Contract/Temporary)

Job Locations US-PA-Philadelphia
Job ID
2021-8544

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 established procedures/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.

 

NOTE: This is an ONSITE temporary position for approximately 12-24 months and 2 positions are available.

 

Responsibilities

  • Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (e.g.,: ICH, ISPE, etc.)
  • Compiles and reviews raw data, testing records and results in accordance to cGMP and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained.
  • Compiles and reviews raw data, batch records and test results, including Final Reports in accordance with cGMP, GLP, Code of Federal Regulations (CFR), Points to Consider (PTC) guidelines and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained.
  • 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 Nonconforming events.
  • 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 recognize deviation from accepted practice is required.
  • Normally receives minimal instructions on routine work and detailed instructions on new assignments.

Qualifications

 At least 2 years of relevant laboratory and/or QA experience or equivalent.
 Bachelors’ degree in a Science related field.

 

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.

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