Supports appropriate processing, revision and control of quality documents in the Document Control Room.
Responsible for issuing, receiving and archiving of quality records processed through the QA Document Control Center.
Support following Document control activities:
1. - Support scanning of documents (Incoming materials, sanitization logs, pest con-trol logs, etc.), filing documents, also supports onsite and off-site archiving of doc-uments
- Maintain document storage rooms to ensure accurate archive and easy retrieval.
- Retrieve requested records, including logging out records and following up to ensure prompt record return.
- Order supplies/logbooks, organize batch record binders and Print Lab Data Sheet
- Assist in Batch Record Issuance (e.g. Patient BR, Training BR, qualifications etc.)
2. Support QA Compliance activities such as tracking/following up on projects/tasks associated with QEs/Actions/CAPAs
3. Prioritize tasks based upon departmental objectives and business criticality
4. Support project related activities (e.g. help with, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, quali-fication and facility upgrade activities, IT validation projects) as per area of respon-sibility.
5. Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidances, SOPs etc.).
Provides timely and accurate document support to all GMP functions at CGTDM East Hanover Facility
Communication skills to sufficiently address GMP and logistic related questions with the line unit experts.
Basic knowledge of drug development and CGT development is a plus.
Detailed knowledge of cGMP and document management, working knowledge of safety and environmental regulations and guidelines.
Good organizational skills.
Technician > 3 years’ experience
Bachelor with > 1 years’ experience