Sr Quality Assurance Specialist

  • Company: Shire plc
  • Posted: December 01, 2017
  • Reference ID: R0016274

Successfully perform all the primary activities as defined in the job description for a Sr. Quality Control Technician I and Lead QA Technician. Handles and leads multiple projects. Demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. Lead PMT, QWT, Kazan or equivalent focus type group activities are required. Design, lead and perform experiments using sound scientific principles. A functional understanding of FDA, ISO and Quality systems is also required.

Essential Duties and Responsibilities
  • Manage ongoing daily departmental activities for areas of direct responsibility including supervision of assigned and/or unassigned off shift personnel (i.e., swing, weekend, graves as assigned), and when required assist other Quality areas in the successful performance of these activities.
  • Manage activities of self and in-direct reports in achieving defined quality goals in an efficient, accurate and timely manner.
  • Be directly involved in and where appropriate lead multiple process/product improvement projects which may include any of the following - PMT, QWT, Kaizen, 5S or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
  • Lead in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and quality requirements. Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements.
  • Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and where appropriate, assist and support such activities throughout the facility.
  • Provide guidance and coaching for the areas of responsibility as defined in items # 1 through #5 for less experienced individuals within the plant.
  • Must be a recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability.
  • Must have the ability to perform the responsibilities of the Quality Section Manager on an as needed basis.
  • Assists, writes and/or review validations for equipment, product changes and computer systems.
  • Assists with vendor audits/assessments and provides ongoing feedback related to quality issues.
  • Assist in investigations, problems solving sessions and process troubleshooting as assigned.
  • Responsible for Risk Assessment, Investigation Review/ Approval and Product Disposition in Exception Management System for assigned Non-Conformance Reports.
  • Result Driven- manufacturing process simplification and also yield improvement ideas, generate breakthrough solutions
  • Ensures the RFT success to meet the on time release of lot to our patients.
  • Must be willing to work flex hours and rotations, if necessary.
  • Understand scientific strategies and be able to invent new methods or new avenues of investigation.
  • Good interpersonal/communication/influencing/negation skills.
  • Good project management skills.
  • Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
Education and/or experience

  • Bachelor's degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering is ideal.
  • Lead Auditor training, ISO Lead Assessor training, with 2-3 years of experience in auditing techniques, interpreting regulations or quality systems.
  • Minimum of 5-8 years of experience in Quality, or related field in the medical products industry.
Physical Demands
  • Must be able to lift and carry up to 10 lbs.
  • In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
Working Environment
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
  • Will work in a cold, wet environment
  • Must be able to work multiple shifts, including weekends.
  • May be required to work in a confined area.
  • Some Clean Room and cool/hot storage conditions.

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