Quality Assurance Document Control Associate SpecialistThe 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 include a Bachelor's degree or equivalent, with a minimum of 5 - 8 years of relevant document control records management experience in a cGMP/FDA regulated environment. Must demonstrate strong communication and customer service skills, experience with Part 11 adherence regarding scanning of records and electronic archiving, and strong computer skills with MS Office and Quality Systems.Duties and responsibilities include the organization of cGXP controlled document files within the Document Center, managing the Document Center Archive room, thorough knowledge of Records Management, Scanning and organization functions, and following Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.