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Document Control
3 months ago
6 Months
Norwood, MA
PR: $40-50/hour
Job Summary
The Specialist role supporting Document Control and Records Management will be responsible for maintaining documents in compliance with business needs and regulatory expectations in addition to supporting process improvements in the document control and records management areas. The individual will be responsible for formatting and administration of paper-based and electronic document workflows as well as chain of custody, issuance, and archival of paper records. Excellent organizational skills, the ability to work independently on multiple tasks, and the ability to work in a fast-paced environment are required.
Job Responsibilities
- Support cross functional teams in processing document requests, document approval, and document archival.
- Issuance and reconciliation of paper records (i.e., batch records, logbooks, protocols)
- Manage the archival of all GMP documentation both on-site and off-site (organization and maintenance of the on-site archival room)
- Develop and implement process improvements for Document Control and Records Management processes.
- Assist in document control process improvements including document types, lifecycles, and workflows in eDMS
- Revise SOPs related to Document Control, Records Management
- Collaborate with cross-functional teams to identify efficiencies around maintenance/control of paper-based documents.
- Provide document control/records management support for internal/external audits and inspections.
- Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
- Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
- Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
- Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
Education & Qualifications
- Education: BS or MS degree, preferably in Sciences or Engineering
- Experience: 7-10 years of Quality Assurance experience in pharmaceutical industry OR BS degree with 3-5 years of experience/MS degree with 2 years of experience.
- Demonstrated aptitude or ability to learn to gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards).
