Specialist role to provide Quality oversight in manufacturing operations at the site and monitor processes for adherence to established procedures/regulatory compliance. As part of an inter-departmental team environment, collaborate with subject matter experts to resolve any Quality issues or improvements for new and existing clients, including being the QA single point of contacts for clients. Review and approve manufacturing batch records, non-conformances, deviations, and CAPAs in accordance with cGMP. Prepare Certificate of Analysis for batch release.
Details:
100% Onsite at our Philadelphia locationSchedule: Wednesday to Saturday 2 PM to 12 AM Responsibilities• Review and approve low-risk non-conforming events (NCE), deviation and CAPA.
• Review and approve pre-executed batch records for assigned clients
• Review and approve executed Manufacturing batch records.
• Prepare Manufacturing release checklist and COA’s
• 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.
• Interact with project team to assure that project requirements and details are understood and effectively translated into MFG records.
• Interact with QA batch record reviewers to communicate project requirements and assure that details are adequately translated into Manufacturing records.
• Work with document reviewers to compile and review raw data, batch records and test results, including Final Reports and CoA’s, in accordance with cGMP, Code of Federal Regulations (CFR) and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained.
• Revise SOPs as necessary.
• Review and approve document change requests.
• Participate in quality and process improvement initiatives, and project teams.
• Coordinate execution of Manufacturing Suite inspections.
• Participate as needed to support internal audits, client audits, supplier audits, regulatory inspections.
• Contact for on-site client visits.
• Maybe required to work Holidays and weekends
• Contributes to the overall operations and to the achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
• Thorough understanding of Good Manufacturing Practices
• Other duties as assigned
• Potential to be selected for Visual Inspection Qualification. Selected individuals are required to inspect final product in a light booth to detect defects and record the pass/fail results of their inspection
• 3 - 5 years or more of relevant experience or equivalent
• Bachelor’s degree in a Science or equivalent experience
Knowledge / Skills / Abilities:
• Knowledge of cGMP requirements
• Knowledge of Root Cause analysis techniques required.
• Extensive experience writing and/or reviewing/approving Laboratory Investigations / Deviations / CAPA’s preferable.
• 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.
• 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.
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.
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