Pharmatech Associates, a USP company
Pharmatech Associates, a USP company is hiring: Technical Writer in San Rafael
Pharmatech Associates, a USP company, San Rafael, CA, United States, 94911
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.
- Bachelors Degree, preferably in the Life Sciences or Engineering field
- Technical writing experience including manufacturing procedures and instructions
- Minimum of 2+ years industry experience in a cGMP environment
- Authoring and reviewing documents and working with business partners (other departments and QA), vendors, and SMEs on content.
- Excellent written and oral communication skills, ability to work in a fast-paced team oriented environment.