Documentation Specialist
On-Site in Sharon, MA
6 Month Contract (Potential Extensions)
What You Will Achieve:
The QS Documentation Specialist II supports the documentation activities in support of product production and release. The position has a great deal of interaction with many other departments, including Production, Purchasing, Materials, Quality Assurance, Quality Control, Regulatory and Logistics. The primary responsibilities are SmartSolve Document Management routing and approval, ensuring security and easy retrieval of the controlled files, batch record issue and supporting production needs.
- Perform SmartSolve Document Management routing, review, and approval activities. Issue training Packets, as needed.
- Maintain databases for Document Control room inventory
- Control and maintain Device Master Records, Equipment History Files, and Process Flow Diagrams
- Responsible for filing and maintaining archived documents.
- Responsible for assisting with the destruction of documents that are outside of the required retention period and/or assisting with the preparation of records for storage offsite
- Responsible for ensuring that records are maintained, secure, and retrievable throughout defined record retention periods
- Review Facilities documentation for compliance prior to filing in the Equipment History Files.
- Communicate any areas of deficiency to the responsible individuals
- Maintaining the cell bank database in Excel by entering new binders into inventory and tracking the hard copies taken for reference.
What You Need to Achieve It:
· Requires Associate’s Degree or equivalent
· 3 - 5 years of related experience in a GMP/GLP regulated environment
· Documentation experience required
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser:
Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser:
Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. "