Maintaining the proper documentation related to Quality.
Assist in SOP development, editing, review and generation.
Assist in Controlled Document development, editing, review and generation.
Assist in Quality review of Batch Record Documentation.
Assist in troubleshooting of all Quality issues.
Compilation and review of Manufacturing Summary documentation for IND_Ready™_ contracts by customer request.
Assist in TSE/BSE request, review, filing and tracking.
Assist in approval, management, and tracking of the Approved Order List.
Assist in Issuing, approval, release and review of contract documentation, Quality testing documentation, and contract plasmid products.
Assist in assigning Lot Numbers, entering orders and issuance of Contract books and component books for IND_Ready™ _contracts.
Assist in performing the Quality documentation tasks for approval of SOPs and Controlled documents.
Assist in review of New Equipment Forms, Equipment Maintenance (EM) Forms, Vender Maintenance Calibration (VMC) Forms, and Equipment Relocation (ER) Forms and auditing of completed work.Assist in completion of Monthly Quality Audits.
Solution Preparation form review.
Serve as a member of the safety committee as required.
Assist in authoring project reports and PDRs.
Responsible for releasing dedicated components for IND_Ready™ _contract.
Other duties as required
Qualifications
Qualifications
BS in Biology, Chemistry, Microbiology and Molecular Biology (or equivalent) or equivalent work experience.
Strong attention to detail.
Solid communication skills.
Additional Information
WHY WORK HERE:
Collaborative team that values a positive work culture
Ability to work remotely most of the time
Work with well-known brands and organizations
Spanish lessons provided to all employees
Your information will be kept confidential according to EEO guidelines.