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Quality Assurance Engineer

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

Job Description:

Quality Assurance EngineerTemp to Hire$38.00 per hourIn this fast-paced environment, Quality Assurance Associates/Engineers work collectively to provide continuous oversight of all GMP operations encompassing materials, manufacturing, testing, and facility operations. This position will also be responsible for assisting with the administration and continuous improvement of the QMS. These responsibilities require a high degree of accuracy and attention to detail. The ability to work well independently as well as in a team environment is crucial as the position reports to Quality Assurance Supervisor and communicates regularly with all levels of personnel within the Company's--external vendors and clients.Job Duties

  • Provide GMP support for the contract manufacture of protein biologics and cell/gene therapies to enable and support early-phase (i.e. Phase 1) clinical trials.
    • Drive continuous improvement to key quality operational procedures and systems including authoring new SOPs as well as SOP revisions and proving training on these procedures and systems.
    • Review/approve key manufacturing, testing, equipment, utilities, facilities documentation including batch records, deviations/investigations, test data, and qualification protocols and reports.
      • Provide Quality input and approval on deviations, investigations, environmental monitoring excursions, Out of Specification (OOS) results, Corrective and Preventive Actions (CAPA) and change controls.
      • Provide Quality authorization of line clearance of GMP areas.
      • Assist in establishing specifications for equipment, processes, raw materials and final product in conjunction with Subject Matter Experts and clients.
      • Issue documents and labels to Operations for product runs and reconciliation of documents and labels after a production run; ensure approval of batch specific final product labels
      • Assist in all aspects of document control.
      • Assist in performing audits of the facility and follow up on reconciliation of any findings via formal reports and responses.
      • Resolve vendor issues including aspects of supplier corrective action procedures.
      • Support materials management including release/quarantine of materials and investigation into non-conforming materials.
      • Assist in the administration of the GBF site-wide training program.
      • The position will require occasional evening/weekend work to accommodate operational activities that may occur outside of normal business hours. While not typical, this irregularity of work hours should be expected. Minimal travel is expected.Minimum Qualifications:
        • A master's degree in Engineering, Biological Sciences, or a related field.
        • 3+ years of experience in a Quality Assurance operational role, mainly in the production oversight of pharmaceuticals, biologics and/or cell/gene therapies.
        • Demonstrated experience in batch record review and analytical review of GxP batches
        • Solid knowledge of Good Manufacturing Practices (GMPs) in regard to clinical manufacturing operations and compliance with 21 CFR 11, 28, 210, 211, 600, 1271, and FACT regulations.
        • Demonstrated ability to operate an electronic quality management system.Preferred Qualifications:
          • Experience with aseptic techniques, gowning practices and general operations within an ISO-controlled, clean room environment.
          • Comprehensive understanding of risk management and root cause analysis tools (e.g. FMEA, Ishikawa, Fishbone, etc.).
          • Operational experience leading materials non-conformances, deviations, investigations, out of specification results, and corrective/preventive actions.
          • Experience working in a Just in Time (JIT) environment relating to manufacturing, material procurement, kitting, release and distribution of finished product.Knowledge, Skills and Abilities:
            • Ability to work in a fast paced, highly collaborative environment with a demonstrated commitment to develop long-term relationships with colleagues, clients, and community is required.
            • Must be a goal-oriented, self-starter capable of operating both independently and as a part of a team in a start-up environment.
            • Detail oriented with good organizational, communication and time management skills.
            • Able to identify, communicate, report and correct quality concerns effectively and efficiently.
            • Good oral and written communication skills across all levels of internal personnel, company staff, vendors or clients.
            • Experience in the Microsoft Office suite including MS Word, Excel and Outlook.
            • Administration and routine use of electronic document management systems (e.g. Documentum, etc.), strongly preferred.
            • Operational use of electronic resource planning (MRP/ERP) and/or inventory management systems, highly desirable.Why 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, Aurora , Quality Assurance Engineer, Other , Aurora, Colorado

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