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Quality Systems Coordinator
2 months ago
We are seeking a highly organized and detail-oriented Quality Systems Coordinator to join our team at WuXi AppTec. As a key member of our quality assurance team, you will be responsible for administering document control processes, ensuring compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) for Laboratory Studies.
Key Responsibilities- Manage the day-to-day aspects of the archival process, including record retention, obsolescence, and archival.
- Coordinate training documentation, including creating training modules for new employees based on functional management input.
- Administer the document change process, including assigning tracking numbers, issuing documentation, and making documents effective upon completion of training requirements.
- Perform the issuance, maintenance, and archival of controlled documents, including SOPs, Log Books, Batch Records, Training Records, and Cleaning Records.
- Ensure document maintenance is adhered to, including biennial SOP reviews.
- Provide and prepare documentation and materials for various reporting forums for internal and external customers.
- Lead and/or participate in quality system reporting forums assessing compliance with cGMP and other applicable regulations.
- 3-5 years of relevant experience or equivalent.
- Bachelor's degree in a Science-related field or equivalent experience.
- 1 year GXP experience or equivalent training and/or experience.
- Ability to accomplish duties through the use of appropriate computer equipment and software (especially Microsoft Word, Excel, and Outlook).
- Proficient in multitasking and time management.
- Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
- Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication.
At WuXi AppTec, we value integrity and dedication, working together and sharing success, and doing the right thing and doing it right. We are committed to providing opportunities for internal growth and offer a dedicated and accessible Human Resources team.
We provide 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.
