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Pharmaceutical Quality Assurance Specialist: Technical Writing
Ref No.: 18-38486
Location: West Point, Pennsylvania
Position Type:Contract
Job Category:Biotech/Pharmaceutical
Benefits:401K, Dental Insurance, Medical Insurance
*1 year contract position with additional opportunity based upon performance and continued business need*

The company: Our client is a global healthcare company. The Company offers health solutions through its prescription medicines, vaccines, biologic therapies and animal health products. It operates through four segments: Pharmaceutical, Animal Health, Healthcare Services and Alliances. The Company's Pharmaceutical segment includes human health pharmaceutical and vaccine products marketed either directly by the Company or through joint ventures. Human health pharmaceutical products consist of therapeutic and preventive agents, generally sold by prescription, for the treatment of human disorders. The Company sells its human health pharmaceutical products primarily to drug wholesalers and retailers, hospitals, government agencies and managed healthcare providers, such as health maintenance organizations, pharmacy benefit managers and other institutions. Vaccine products consist of preventive pediatric, adolescent and adult vaccines, primarily administered at physician offices.

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 needed. 

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 

Pay Rate: $35.00 per hour
Drug and background screenings required

On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics. Additionally, our client for this opening does not permit the use of Corp-to-Corp (C2C) candidates.