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For your reference, we have included the original job posting below.
Compliance Specialist
Job Number:
23856527
Company Name:
Info Technologies, Inc.
Job Location:
Marietta, PA US
Job Category:
Management & Business
Compliance Specialist
Reference # : 10-02698 Title : Compliance Specialist Location : Marietta, PA Experience Level : Start Date / End Date : Mon, May 3, 2010 / Tue, Nov 2, 2010 Description
Specialized Knowledge:
Basic Requirements:
· B.S or B.A in a technical discipline, preferrably Microbiology, Biology/Virology, Biochemistry, Chemistry or Pharmacy. Degree in other discipline if sufficient technical depth has been achieved from profressional experience. · Minimum of 3 years pharmaceutical experience investigationg manufacturing deviations either in a QA or manufacturing role; preferrably in Biologics Secondary Manufacturing . · Lean and Six Sigma knowledge evidenced by training/certification or statistics competency. · Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities. · Demonstrated problem solving and investigational skills. · Knowledge of GMP?s, NIH Guidelines, FDA and other regulatory agency requirements sufficent to apply to quality operations and compliance. · The ability to commuincate both verbally and in writing with all levels both inside and outside of the oragniziation. The ability to clearly write technichal documentation as necessitated by regulatory agancies an internal policy. · Ability to establish and maintain working relationships with staff and the abiliy to analyize data and implement changes. · Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA. Ability to work in a high complex matrix environment. · Able to prioritize and decide appropriate course of actions and to effectively implementing decisions. · Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions. · Able to maintain attention to detail while executing multiple tasks · Able to perform job duties with minimal supervision.
Preferred Requirements: Relevant to the role, but not critical/essential · User experience withSAPis highly preferred. · Work experience with parenteral dosage forms (aseptically filled vials, syringes); biologics is highly preferred · Biologics Secondary Manufacturing .
