Title: Technical Writer
Position is responsible for drafting and revising Batch Production Records (BPR), Line Packaging Records (LPR), and Packaging Work Orders (PWO) for use in PDS and Commercial manufacturing and packaging to meet manufacturing & packaging schedules.
- Prepare documents, circulate for review and approval, and make available document request packets for requestors to complete all required information for the master document requested.
- Consult with technical personnel on process requirements, manufacturing/packaging equipment and specifications, as well as consult relevant SOPs to assure compliance, and complete necessary support tasks for document issuance (A110’s, PMX, filing, etc.).
- Obtain information in a timely manner, manage document changes from many sources, prioritize work to meet tight timeframes, and build consensus with multiple reviewers.
Minimum 1 year experience in pharmaceutical industry required. Additional industry experience is preferred. Must possess excellent organizational and interpersonal skills, strong oral and written communication skills, and the ability to adjust to changing priorities. Must have the ability to work independently and meet strict deadlines, as well as be proficient with Microsoft Office (especially MS Word). Must have a significant level of attention to detail, and basic knowledge of current Good Manufacturing Practices. Prior document management/control or administrative experience is preferred.
Bachelor’s degree. Associate's Degree, high school diploma, or equivalent will be considered for highly qualified candidates.