Senior Technical Writer in Pearl River, NY

At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business. We currently have an opening in our Compliance Manufacturing Fill Finish PPU Department for a(n) Senior Technical Writer, at our Pearl River, NY facility (located on the Rockland County, NY/Bergen County, NJ border). JOB SUMMARY: Incumbent will be responsible for writing/revising Departmental Master Batch Records (MBRs), Departmental and Global Standard Operating Procedures/Level III Documents (SOPs) and assist in creation of Change Controls with guidance from the Subject Matter Experts (SMEs) from the Fill Finish PPU. Responsibilities also include tracking of the MBRs/SOPs within the department during the review/approval cycle, and reporting metrics on a weekly basis. Incumbent will develop/revise job aids, training plans, presentations, knowledge assessments and skill checks. All SOP related documents are processed within the approved system for the Biotech division, GXPharma. All MBR revisions are processed within the approved system for the Biotech division, currently a paper system, future MES system. Incumbent will be responsible to train/mentor new technical writing staff. Documentation Manager will assign incumbent to projects and teams to support current documentation requirements and future documentation process improvements. JOB ACCOUNTABILITIES: *Write/revise SOPs/MBRs/CCs in response to investigation and audit commitments, production/process improvements and compliance requirements. Revision of SOPs to meet the two-year review cycle. *Work with the Document Coordinator, the Sr. Technical Writer will coordinate SOPs/MBRs and provide guidance/instructions to the other departmental technical writers. *Establish/maintain a system for the departmental batch record documentation to ensure that the MBRs are tracked and completed in the assigned timeline. *Act as liaison between Manufacturing and QA and all supporting groups in responding to commitments, process changes and change control items concerning SOPs/MBRs/CCs. Assist in auditing documents to ensure that the procedures in place are in conformance with Level I Policies and Level II Conformance Standards. *Provide weekly input to Document Coordinator for monthly metrics from all technical writers consisting of number of documents assigned, drafted, reviewed, approved, issued and effective. *Work with Trainers and SMEs to write/revise training plans, presentations, knowledge assessments, job aids and skill checks for documents on which technical writing has been performed. *Track SOPs/MBRs/CCs within the department during the documents lifecycle. Facilitate completion of documents to meet specified timelines. BASIC QUALIFICATION: BS in Biological Sciences or related field -Minimum 4 years. Strong computer skills, e.g. Word/Excel (tables/styles, formatting, etc.) are required. Attention to detail and proofreading skills are required. Good communication, organizational, and writing skills are required. Knowledge of GMPs, MIRs , Change Controls, and Aseptic Processing is preferred. EXPERIENCE: 4-5 years experience in creation/revision/maintenance of production SOPs, Batch Records is required. 3-5 years experience in Pharmaceutical production and/or QA/QC is preferred. Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs. For more information and to apply online, please visit us at: www.wyeth.com/careers Wyeth is an Equal Opportunity Employer, M/F/D/V. Search Firm Representatives: Please Read Carefully. Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all res To Apply to this job go to http://www.GadBall.com or click here