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Manager, Incoming Quality Assurance - Bloomsbury, NJ

Company: Kelly Services
Location: Bloomsbury
Posted on: April 9, 2021

Job Description:

Manager, Incoming Quality Assurance - Bloomsbury, NJPosition Overview:

  • Responsible for managing all Quality Assurance aspects of compounding sterile pharmaceuticals for compliance within the facility.
  • Operates within the legal and regulatory compliance, producing a quality product.
  • Operates the area as the manager over the QA operations/staff, coordinating day to day functions
  • Manages all Manufacturing QA staff providing learning and development where appropriate
  • Ability to make QA decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
  • Responsible for timely and accurate in process review of batch records and QA checks within the manufacturing process
  • Provides review/approval of Deviations / Investigations, CAPAs, Change Controls
  • Generates procedures related to Manufacturing QA functions / activities
  • Designs and maintains the environmental monitoring program including environmental and personnel monitoring results that exceed alert or action limits and interpreting results
  • Trains personnel on appropriate aseptic techniques and gowning techniques
  • Periodically review records to verify that quality standards for each drug product is met
  • Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
  • Prepares and submits weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities
  • Responsible for maintaining QA records associated with internal and external testing
  • Responsible to maintain all testing equipment in compliance, calibration and certification
  • Assists in developing policies and procedures related to QA
  • Promptly communicates with Operations regarding complaints, product issues/variances
  • Enforces applicable personnel policies and proceduresQualifications:
    • Bachelor's Degree in Life Science or other related field required
    • 5 years prior experience in Quality Assurance /Laboratory/ cGMP / FDA regulated industry
    • 3 years of supervisory or management experience required
    • Experience training personnel on aseptic techniques and appropriate gowning techniques
    • Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP's and have demonstrated strength in problem solving and resolutionFor immediate consideration apply today!Questions? Please reach out to Dustin at Kelly--?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, Bethlehem , Manager, Incoming Quality Assurance - Bloomsbury, NJ, Executive , Bloomsbury, Pennsylvania

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