Since 1968, ABC Laboratories has delivered expert scientific support to companies working to improve human and animal health. As a member of the ABC team, you’ll work alongside respected technical experts dedicated to scientific excellence in a process driven regulatory compliant environment. Our laboratories are modern. Our instrumentation is state of the art. And our business is thriving, creating important career opportunities. More than 400 people are building their careers with ABC Laboratories. See what it’s like to do what you love and love where you live! Visit www.abclabs.com to learn more about our company and our community.
The Document Control Specialist maintains, changes and distributes controlled documents, including GXP documentation
Job Duties and Responsibilities:
- Responsible for maintaining and tracking business and GXP documents and electronic records such as, but not limited to: Standard Operating Procedures, forms, methods, and GXP documents including but not limited to: instrument logs, calibration verification procedures, qualification protocols.
- Issue methods and batch records.
- Issue document and equipment change controls.
- Routes and tracks documentation through the organization for review and approval.
- Provide assistance to Quality Assurance personnel by providing documents including but not limited to SOPs as requested during audits.
- Process (scan, verify and prepare TOC) regulatory documents including GXP data.
- Performs other related duties as required and directed.
- High school diploma or equivalent.
In addition to minimum requirements listed above, will assess against preferred qualifications:
- Some experience with regulatory guidelines (e.g., GLP, cGMP, 21 CFR Part 11, Quality Systems Regulations) in order to implement document control procedures, preferred.
ABC Laboratories regrets that it is unable to sponsor employment Visas or consider individuals on time-limited Visa status for this position.
Analytical Bio-Chemistry Laboratories, Inc - 2 years ago