Must Have List :
5 years of experience with the following :
- Library Science
- MS Office including Word, Adobe, Visio.
- Document Scanning experience
- FDA Documentation & Compliance like 21 CFR Part 11 / CGMP
- Ability to manage competing priorities
- Accuracy and Attention to Detail
Schedule :
This person may be required to work weekends. End date for this contract is 31 DEC 2024.
PURPOSE AND SCOPE OF POSITION :
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for Client Jump site records management. Responsibilities include but are not limited to receiving and reconciliation of GMP records, management of scanning, archival and retention of GMP records.
REQUIRED COMPETENCIES : Knowledge, Skills, and Abilities :
Education : Bachelor's degree or equivalent. Library Science a plus
Experience Basic Qualifications :
Minimum of 5 - 8 years of relevant document control records management experience in a cGMP / FDA regulated environmentStrong communication and customer service skills.Experience with Part 11 adherence regarding scanning of records and electronic archiving.Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)Must demonstrate the following behaviors consistently : Innovative, proactive, and resourceful; committed to quality and continuous improvementAble to prioritize, manage time well, multi-task, and troubleshoot effectivelyAbility to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverablesPossess project management skills.Strong knowledge of cGMPs and domestic regulatory requirementsMust complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal networkDUTIES AND RESPONSIBILITIES :
Responsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed.Assist with managing the Document Center Archive roomThorough Knowledge of Records Management, Scanning and organization functionsFollow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests
