What are the responsibilities and job description for the QA Documentation Specialist position at Katalyst CRO?
Job Description
- Implement, control and coordinate changes in documentation. Facilitates the updating and routing of controlled documents, including, but not limited to, Governance and Procedure documents, Master Forms and Master Batch Records within the eDMS.
- Review documents, review document change requests and route document change requests to process document creation, maintenance, and implementation in eDMS.
- Control/distribution of controlled documentation.
- Preparation of records for issuance to production.
- Organize and maintain the Document Control System to meet current regulatory requirements.
- Manage the change process for manufacturing documentation consisting of SOPs, policies, manufacturing documentation, specifications and other controlled documents.
- Review, edit and process changes to controlled documentation such as procedures, manufacturing records, forms etc. in an electronic document management system.
- Ensure proper approvals have been obtained prior to final release of document and coordinate effective dates with departments.
- Preparation of records for issuance to production.
- Coordination and maintenance of the periodic review system.
- With minimal supervision, complete special projects and routine work on schedule.
- Education and Experience:
- Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
- 3 years' experience in quality assurance, quality oversight or relevant experience. Experience in regulated pharmaceutical/medical device industry and document management areas preferred.
- Proficient in Microsoft Word and Excel. eDMS experience (Veeva Vault) preferred.
- Excellent proofreading skills. Excellent verbal and written communication skills. Good analytical, decision-making and problem-solving skills.
- Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
- Excellent interpersonal skills.
- Ability to identify, communicate and follow through to completion action plans to resolve problems.