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Technical Writer/Scientific - III (Senior)
Ref No.: 18-15497
Location: West Point, Pennsylvania
Under the direction of the Associate Director of Quality Control process Change Controls to completion. Update and author change control documents. These Change Control documents include the Standards used for testing to release products and the Protocols used to qualify the Standards. Work with initiators to update the change controls including check on the correct Materials and Impacted Products for the change control. Work with Quality and Regulatory personnel to complete them. Issue the Reagent Table and the History bi-monthly. Maintain and update spreadsheets to track the Reagent Table. Support new and in-line vaccine programs • Provide analytical assay support for in-line product improvement studies. Provide technical support for new and in-line products • Participate in departmental and cross functional project teams • Document work as required for GMP compliance

Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years experience in the Pharmaceutical Industry. Ability to perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies • Proven ability to work independently and as part of a team, self-motivated, adaptable, and a positive attitude. Strong scientific, computer, organizational, and documentation skills, attention to detail. Technical/Scientific report writing is a plus.