Quality Assurance Manufacturing Specialist II
2 weeks ago
Overview:
A Specialist role to provide Quality oversight in manufacturing operations at the site and monitor processes for adherence to established procedures/regulatory compliance.
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.).
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:
- 7 years or more of relevant experience or equivalent
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 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.
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