Katalyst CRO
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QA Documentation Specialist
role at
Katalyst CRO .
Get notified about new Quality Assurance Specialist jobs in
Branchburg, NJ .
Responsibilities
Implement, control and coordinate changes in documentation; facilitate the updating and routing of controlled documents, including Governance and Procedure documents, Master Forms and Master Batch Records within the eDMS.
Review documents and document change requests, and route them to process document creation, maintenance, and implementation in eDMS.
Control and distribute controlled documentation.
Prepare 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 documents and coordinate effective dates with departments.
Coordinate and maintain the periodic review system.
With minimal supervision, complete special projects and routine work on schedule.
Qualifications
Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
3+ years of 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.
Ability to work both in a team setting and independently; works well with manager guidance to complete tactical objectives while managing own time effectively.
Excellent interpersonal skills.
Ability to identify, communicate and follow through to completion action plans to resolve problems.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
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QA Documentation Specialist
role at
Katalyst CRO .
Get notified about new Quality Assurance Specialist jobs in
Branchburg, NJ .
Responsibilities
Implement, control and coordinate changes in documentation; facilitate the updating and routing of controlled documents, including Governance and Procedure documents, Master Forms and Master Batch Records within the eDMS.
Review documents and document change requests, and route them to process document creation, maintenance, and implementation in eDMS.
Control and distribute controlled documentation.
Prepare 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 documents and coordinate effective dates with departments.
Coordinate and maintain the periodic review system.
With minimal supervision, complete special projects and routine work on schedule.
Qualifications
Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
3+ years of 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.
Ability to work both in a team setting and independently; works well with manager guidance to complete tactical objectives while managing own time effectively.
Excellent interpersonal skills.
Ability to identify, communicate and follow through to completion action plans to resolve problems.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
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