Quality Assurance Compliance Specialist

Overview

Primary Quality Assurance Representative for review of GLP Final Reports, GMP Certificates of Analysis (CoA’s), Assay Validations, deviations, and CAPAs. Reviews laboratory testing data or manufacturing batch records in accordance with current Good Manufacturing Practices (cGMP consults with QA Management to resolve complex quality issues in a timely manner.

Responsibilities

• Focused QA Representative on review/approval of Non-Conforming Events (NCEs), Deviations, Laboratory Investigations (OOS), and CAPA’s; will coach/mentor Laboratory personnel in development of technical writing skills. • Ensures site adherence to Quality Systems.• Perform timely review of complex study files, such as: Assay Validations, Process Validations, and Viral Clearance.• Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.).• Maintains awareness of activities by routine direct observation of testing laboratories and manufacturing suites. Interact frequently with operations/facility staff to provide quality perspective on routine operations and support systems. Address conditions/practices with appropriate personnel, documents and reports findings to Management.• Compiles and reviews raw data / laboratory test results, including Final Reports and CoA’s, in accordance with cGMP, cGLP, 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.• Write and revise SOPs as necessary.

Qualifications

• 7 or more years of experience• Bachelors’ degree in a Science related field or equivalent experience

 

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.