What are the responsibilities and job description for the Manufacturing Operations Specialist I position at WuXi AppTec Inc?
Overview:
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.
Our Values:
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.
Responsible for providing compliance support to the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).
Responsibilities:
- Identifies, understands and able to explain the ‘why’ of acceptable and unacceptable practices, is able to make suggestions to improve performance
- Performs basic analysis, interprets, and draws conclusion of scientific and process data per good document practices
- Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands ‘why’ behind the regulations.
- Identifies, communicates, addresses and improves simple cGMP compliance and regulatory gaps and issues
- Improves the efficiency and execution of SOPs and right first time of batch record execution.
- Trains others on basic SOPs, equipment, systems and unit operations
- Participates, provides information in the development of and authors basic technical documents such as non-conforming events, deviations, CAPA’s, action plans and change controls
- Suggests, participates and implements continuous improvement ideas
- Identifies, participates, suggests solutions and leads basic technical problems
- Aid Manufacturing to continuously improve and install “permanent inspection readiness” mindset, culture, operation, processes and systems
- Support, coach, guide, teach and assess the Manufacturing facility, equipment, documents, processes, systems and people for audits and inspections
- Prepares, coordinates, manages, participates, supports, presents and represents as an SME during regulatory inspections and client audits
- Interface with Manufacturing, QA, Support Functions and auditors/inspectors, during audits and inspections. Activities may include presence or presenting in the front room, preparing SMEs or presenters and representing or acting as the MFG lead in the backroom
- Support coordination and response for MFG and related area audit and inspection responses in a satisfactory and timely manner
- Support closure of CAPAs resulting from audits and inspections
- Support, coordinate and manage prospective and current non-audit client tours
- Communicate with clients on compliance issues and corrective actions surrounding PHL audits.
- Assume a contributing role in compliance projects
- Support and prepare metrics/KPIs as a means to drive improvement of performance
- Interacts frequently with groups
- Regularly coordinates with groups
- Performs well under minimal supervision and starts to work independently on basic tasks and processes
- Ideally, possesses lean/six sigma knowledge and experience
- High School diploma and over 4 years of relevant experience or
- Associates’/Bachelor’s (science preferred) degree with over 2 years of relevant or equivalent experience
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.
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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