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
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Review and approve disruption of controlled environment (DCE) documentation
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Perform aseptic processing training for manufacturing and support personnel
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Perform visual inspection of finished products for designated clients
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Review and approved executed batch records
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Review and approved deviation, non-conformance event (NCE) and change control
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Compile and review raw data, batch records and test results, including Final Reports and CoA’s, in accordance with cGMP
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Prepare manufacturing Certificate of Analysis for batch release
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Generation of Manufacturing batch records
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Archiving of executed batch records and associated documentation
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Approval of document change requests (DCRs)
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Release of raw materials to support manufacturing operations
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Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.).
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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.
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Participate in quality and process improvement initiatives, and project teams.
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Participate as needed to support internal audits, client audits, supplier audits, regulatory inspections.
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Required to work on holidays and weekends
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Contributes to the overall operations and to the achievement of departmental goals
Qualifications:
Experience:
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5 - 7 years or more of relevant experience or equivalent
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Bachelor’s degree in a Science related major
Knowledge / Skills / Abilities:
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Knowledge of Root Cause analysis techniques required.
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Extensive experience writing and/or reviewing/approving Laboratory Investigations / Deviations / CAPA’s preferable.
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Sound knowledge and interpretation of FDA and EU cGMP requirements
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Works on complex issues where analysis of situations or data requires an indepth evaluation of variable factors
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Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways
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Ability to accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, and Access).
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Ability to record data accurately and legibly.
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Ability to use judgment as dictated by the complexity of the situation.
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Very good oral and written communication skills.
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Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
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Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication.
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Proficient in Microsoft Office (Excel, Word, PowerPoint, Visio)
Our Values:
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Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
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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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WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin