USA-Quality Manager III (Engineering)

Quality Manager III (Engineering)Swiftwater PA, 1837012 Months Description:This position is responsible for providing Quality & Compliance oversight to site validation projects related to Drug Substance Vaccine manufacturing.We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.Main Responsibilities:· The individual would be part of the Site Quality Organization and will participate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Drug Substance Vaccines and will review and approve validation related studies for assigned areas.· These assigned areas would include validation lifecycle activities such as Validation Planning, Biotech Process Validation, Equipment and Facility Qualification and Validation Risk Management.· This position has signatory responsibilities for validation/qualification documents within assigned areas.· Candidates should have some knowledge in biotech manufacturing processes (i.e. viral antigen production).· Excellent communication skills and teamwork are a must, as individual will be working on cross functional project teams which include members from various organizations within *** such as Manufacturing Technology, Engineering and Regulatory Affairs.· Good interpersonal and influencing skills are important for a candidate’s success in this role.Basic Qualifications:· Bachelor’s degree in Engineering, Science, or related field with 5 years' experience preferably in a cGMP environment.· Strong knowledge of cGMP regulations and quality standards applicable to pharmaceutical manufacturing.· Proficient in relevant computer systems and software used in validation and quality management (e.g., LIMS, TrackWise, SAP).· Ability to effectively communicate technical information to diverse stakeholders, including technical and non-technical audiences.#TB_PH #ZRCompany DescriptionFounded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website www.talentburst.com or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA

Salary : $77,900 - $98,700