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Quality Assurance Specialist I

2 months ago

PhiladelphiaPAUS, United States WuXi AppTec Full time

The Quality Assurance Specialist - Testing 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.

 

Position Details:

  • Schedule: Tuesday to Saturday 10 AM to 6:30 PM
  • Full Time, Benefitted position
  • 100% onsite

 


• Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (e.g.,: ICH, ISPE, etc.).
• Maintains awareness of activities by routine direct observation of testing laboratories. Interact frequently with laboratory/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, batch records and test results, including Final Reports and COAs, 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.
• Reviews and approves Non-conforming Events (NCE), Deviations, and Laboratory Investigation Reports (LIR).
• Write and revise SOPs as necessary.
• Reviews and approves document change requests.
• Perform timely review of complex study files, such as: Assay Validations, Qualifications, Viral Clearance.
• Perform QA inspections including, but not limited to GLP studies.
• Participate in quality and process improvement initiatives, and project teams.
• Coordinates area training.
• Participate as needed to support internal audits.
• 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.
• Ability to work in a team environment and independently as required


• 4+ years of relevant experience or equivalent
• Bachelors’ degree in a Science related field or equivalent experience

 

Knowledge / Skills / Abilities:
• Knowledge of GLP and cGMP requirements, PTC guidelines and ISO17205 is highly desirable.
• Ability to accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, Outlook, and Access).
• Ability to accurately and reproducibly perform arithmetic, algebraic and geometric calculations.
• 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 interpersonal skills.
• Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication.
• Proficient in Oral & Written communication skills
• Need to be able to read, write and understand English

 

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.