QA Associate III, Regulatory Compliance

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

Job Description:

Kelly Science and Clinical is the world's most recognized brand in science and clinical staffing with more than 100 locations in North America, Europe and the Pacific Rim. Our scientists contribute to the research and development of the next generation of small molecule drugs, biologics and cellular therapies.OverviewWe are seeking QA Associate III, Regulatory Compliance--for one of our clients, a leading global Contract Development and Manufacturing Organization based in Seattle, WA that is committed to bringing--new biopharmaceuticals to market by offering customized services for scale-up and cGMP manufacture of protein-based therapeutics. The incumbent--is responsible for ensuring compliance with internal SOPs and applicable regulatory guidelines and requirements.Responsibilities

• Support with Regulatory Inspection Readiness
• Inspection Preparedness
• Maintain inspection readiness through inspection preparedness program and periodic readiness verification
• Execute against plan (training, document readiness, response preparation and readiness)
• Maintaining the Quality Systems in compliance with cGMP, FDA and ICH applicable regulations.
• Provide support to other functional areas for dealing with Deviations, CAPA, Change Control, Complaints and Recalls.
• Create and update SOPs, company Policies and other GMP documents.
• Support the internal audit program
• Maintain the internal audit schedule
• Coordinate with internal auditors
• Support the program to pro-active management of clients to ensure confidence in Quality systems including:
• Support establishing Quality Agreements with clients consistent with Global standard.
• Ensure communications with client are maintained consistent with Quality Agreement and positive client experience
• Support required client audits and provide observation responses consistent with timeline commitments
• Support Compliance Documentation and Licensing
• Establish a calendar to provide visibility to compliance documentation requirements
• Generate and provide required documentation to clients and Regulatory authorities
• Other duties, as assigned.Qualifications
  • A bachelor's degree--in Biology or related fields.--
  • At least five years of QA or related experience working in a regulatory environment or position (GLP, GCP or GMP) with a minimum of three--years of experience within Biopharmaceutical industry
  • Prior auditing experience preferred
  • Strong understanding of cGMP's and concepts in several quality systems.
  • Demonstrated knowledge of GMP, GCP and both US and foreign regulations (EU, IPAC, ICH) is required.
  • Strong oral and written communication skills.
  • Knowledge of computerized support tools and software for audit tracking and reporting.
  • Demonstrated knowledge of root cause/trend analysis/risk analysis.
  • Demonstrated knowledge of quality processes and compliance.
  • Demonstrated ability to multi-task and work on several projects and problems#TJP2021_SPECWhy 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, Seattle , QA Associate III, Regulatory Compliance, Other , Mukilteo, Washington