Technical Writer Job at Pharmatech Associates in San Rafael

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We are looking for a Technical Writer for a 6 month contract role located in San Rafael, CA.

Responsibilities

• The Technical Writer position will support Manufacturing in the creation and / or revision of Procedures (SOP’s), Batch Records (BR’s), and Electronic Batch Records (EBR’s) pertaining to Upstream, Downstream, and / or Solution preparation process operations. This will include working with Manufacturing Subject Matter Experts to ensure document accuracy and detail.
• Initiation and management of document workflows to ensure adherence to deadlines and coordinating document changes for identified Corrective and Preventive Actions.
• Ensure compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies, and safety practices.
• Write and revise cGMP documentation (Standard Operating Procedures, Production Batch Records and / or Electronic Batch Records) and facilitate the review and approval of documents in a timely manner and within established timelines.
• Ensure documents are technically accurate and consistent with internal style guidelines for format, clarity, flow, organization, and readability.
• Manage work independently to ensure timely implementation of documentation workflows.
• Work with Manufacturing Management and QA Change Control to establish comprehensive implementation plans for document revisions and associated change requests.
• Interact with appropriate departments to establish priorities and deadlines for document revisions.
• Communicate with appropriate departments to ensure changes are understood and compliance with respect to changes is maintained.

Qualifications

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