What are the responsibilities and job description for the Quality Assurance Specialist III position at Wapt?
Overview
Senior role to plan and implement quality requirements, and provide Quality oversight in manufacturing operations at the site. 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 major clients. Reviews manufacturing batch records in accordance with cGMP, and review and approves non-conformances, deviations, and CAPAs. Author and revise departmental SOPs to stay current with changes to GxP including FDA, EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.)
Responsibilities
• Reviews and approves Non-conforming events (NCE) and CAPAs• Reviews and approves Change Controls, Document Change Requests and Technical Transfers • Conducts review of pre-executed and executed Manufacturing batch records in accordance with cGMP and internal procedures in an efficient and timely manner. Assure that investigations/deviations are properly investigated and documented• Interacts with manufacturing management to provide quality perspective on routine operations and support systems. Address conditions/practices with appropriate personnel and determine if issues can be addressed with batch record comments or require escalation• Interacts with project team to assure that project requirements and details are understood and effectively translated into MFG records• Interacts with QA release functions to communicate project requirements, and timeline to enable batch release• Writes, reviews and revises SOPs as required• Participates/Leads internal and client audits, and regulatory inspections • Participates in quality and process improvement initiatives and project teams• Acts as QA single point of contact for designated clients • Attend meeting and represent QA Manufacturing for Quality issues• Given authority to make decision and sign documents on behalf of QA Manufacturing
Qualifications
• 7 years of relevant experience in the biopharmaceutical industry • Bachelors’ degree in a Science related field
New hires must be fully vaccinated against COVID-19 and provide proof of vaccination or receive an approved medical or religious exemption from Human Resources. This offer is contingent upon WuXi ATU verifying your vaccination status or approving an exemption request prior to your start date. If you wish to be considered for a medical or religious exemption, request an exemption by notifying WuXi as soon as possible, but no later than one week before your start date.
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Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
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