- Keeps team current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.)
- Audits raw data in accordance with Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP) and Code of Federal Regulations (CFR) guidelines
- Monitor and maintain quality systems and procedures (SOPs) for adherence to regulatory compliance requirements. Focus on driving continuous quality improvements. Initiates and revise SOPs and Policies as necessary.
- Perform trend analysis, report results and coordinate corrective and preventative actions (CAPA) to drive compliance and quality initiatives. Measure, track and evaluate key quality metrics to support future quality initiatives and resource allocation.
- Lead and/or participates on cross-functional teams and projects representing quality in positive and compliant manner.
- Conduct documentation review and approval including but not limited to: Testing and Manufacturing Batch Records, Cleaning Record, Client Protocols, Training Records, Qualification/Validation Documents
- Review, approve and perform investigations, as needed, and provide guidance for CAPA related to non-compliance situations using creative problem-solving skills.
- Supports QA aspects of the change control processes (equipment, facilities, utilities and document) and ensure are handled in a compliant manner.
- Supports and actively participates, as needed, in client and regulatory audits/inspections.
- Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
- Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work
- Plans, monitors, and appraises direct reports including performance competencies, goals & job results
- Coaches, counsels, and conducts disciplinary actions
- Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards
- Normally receives minimal instructions on routine work and detailed instructions on new assignments.
- HS Diploma or equivalent required and
- 5+ years relevant technical experience and min 2 years in a Lead/Leadership/Supervisory Role
- BS/BA in Science related field preferred; or combination of relevant Experience & Education
- Proficient in Oral & Written communication skills
- Need to be able to read, write and understand English
- Proficient in Microsoft (Excel, Word, Outlook)
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Supervisor Quality Assurance - Butler, United States - WuXi AppTec
Description
WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies.
Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.
Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients.
Our parent company, WuXi AppTec has over 1,800 US-Based employees located with 11 facilities in 8 states. Globally WuXi AppTec spans to morethan 39,000 employees with 32 facilities in 9 countries.
The Supervisor coordinates and oversees the day-to-day aspects of the QA staff, including training and development of QA staff. Monitor and maintain compliance with current regulatory requirements (cGMP, GLP, GTP, CFR, PTC and ICH) and internal SOPs. Drive continuous quality improvement through communication/training, waste reduction, and mistake-proofing. Solicit and implement industry best practices
Knowledge / Skills / Abilities:
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.
