WuXi AppTec

Quality Assurance Manufacturing Specialist II

Job Locations US-PA-Philadelphia
Job ID
2024-12745

Overview

A Specialist role to provide Quality oversight in manufacturing operations at the site and monitor processes for adherence to established procedures/regulatory compliance. High level job accountabilities included activities related to sterility assurance, manufacturing oversight, quality system and release of raw materials.

 

Work Location: 100% Onsite at our Philadelphia, PA Site

Hours: Sunday to Wednesday 8 AM to 6 PM (flexibility in start time to 7 AM or 6 AM available if desired)

 

Responsibilities

  • Review and generate of Environmental Summaries to support batch release
  • Review and approve disruption of controlled environment (DCE) documentation
  • Perform aseptic processing training for manufacturing and support personnel
  • Perform visual inspection of finished products for designated clients
  • Review and approved executed batch records
  • Review and approved deviation, non-conformance event (NCE) and change control
  • Compile and review raw data, batch records and test results, including Final Reports and CoA’s, in accordance with cGMP
  • Prepare manufacturing Certificate of Analysis for batch release
  • Generation of Manufacturing batch records
  • Archiving of executed batch records and associated documentation
  • Approval of document change requests (DCRs)
  • Release of raw materials to support manufacturing operations
  • Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.).
  • Interact with manufacturing management to provide quality perspective on routine operations and support systems. Address conditions/practices with appropriate personnel, documents and reports findings to Management.
  • Participate in quality and process improvement initiatives, and project teams.
  • Participate as needed to support internal audits, client audits, supplier audits, regulatory inspections.
  • Required to work on holidays and weekends
  • Contributes to the overall operations and to the achievement of departmental goals

Qualifications

Experience:

  • 5 - 7 years or more of relevant experience or equivalent
  • Bachelor’s degree in a Science related major

Knowledge / Skills / Abilities:

  • Knowledge of Root Cause analysis techniques required.
  • Extensive experience writing and/or reviewing/approving Laboratory Investigations / Deviations / CAPA’s preferable.
  • Sound knowledge and interpretation of FDA and EU cGMP requirements
  • Works on complex issues where analysis of situations or data requires an indepth evaluation of variable factors
  • Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways
  • Ability to accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, and Access).
  • Ability to record data accurately and legibly.
  • Ability to use judgment as dictated by the complexity of the situation.
  • Very good oral and written communication skills.
  • 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 Microsoft Office (Excel, Word, PowerPoint, Visio)

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

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