Please note that this is a 1 year contract position.
Shift: 8:00am to 5:00pm
*Process controlled documentation to maintain compliance with record retention policies, company procedures, ISO 9001:2015 requirements, and Good Documentation Practices (GDP)
*Scan, verify, and archive paper records into an electronic format, ensuring files are accurate, readable, and easily obtainable when necessary
*Archive paper records in an organized manner for proper storage and help coordinate records for offsite move
*Perform data entries in Excel as part of the records management system
*Provide support in the final review of manufacturing batch records following GDP guidelines. This includes reviewing batch records for errors, working with the manufacturing team to correct errors found during review, tracking errors for the purpose of metrics, and being able to provide GDP guidance and training as needed
*Provide documentation-related metrics to management
*Periodically monitor employee training records to ensure compliance with training requirements and as part of general audit readiness
*Support audits and audit readiness by gathering and organizing necessary documentation when required
*Perform tasks as part of projects to ensure quality or regulatory compliance. This may include working cross-functionally
*Assist the QA team in other related duties as needed to support document control or QA and Regulatory needs as defined by management
BS/BA degree in Chemistry, Life Sciences, Engineering, or a related field or possess a minimum of 3+ years relevant document specialist skills experience in a regulated industry.
*Requires proficiency in the use of Microsoft Office products such as Word, Excel, and PowerPoint, along with familiarity working with Adobe Acrobat
*Strong attention to detail and ability to maintain an organized environment
*Knowledge and experience of document control in a GDP and ISO 9001:2015 or similar environment is preferred
*Comfortable working both independently with minimal supervision and collaboratively across departments or cross-functional teams
*Capable of performing observational feedback and presenting opportunities for process improvements
*Ability to prioritize daily activities to meet goals and deadlines, yet flexible to be able to handle changing priorities
Applicants must provide their phone number. Reference job number A828.