Sr. Specialist, Quality Assurance Compliance, Biologics, Tustin, CA

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

Job Description:

Sr. Specialist, Quality Assurance Compliance, Biologics, Tustin, CAPosition Type/Expected Hours of Work:This role is a full-time, exempt position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5 p.m.Summary:As an individual contributor, performs a wide variety of activities to ensure compliance with applicable quality and regulatory requirements by conducting internal and external audits, data and documentation reviews and analysis. Prepares audit reports regarding compliance findings and concerns and provides recommendations for corrective actions. Coordinates resolution of quality issues with suppliers and monitors quality metrics. Writes and revises SOPs. This position focuses on regulatory compliance, strict adherence to the company's quality policy, in addition to improving and implementing cGMP practices.Objective:

• Support the Director, Quality Assurance Compliance by conducting internal audits of Operations and Quality Systems and external audits of vendors. Follow up on internal and external audit results to ensure appropriate responses during inspections
• Develop solutions to complex issues and Quality initiatives following cGMP regulations
• Perform tasks and work to achieve company goals and organizational objectives.Essential Duties and Responsibilities--include--but are not limited to the following:
  • Follow company policies and procedures.
  • Establish work priorities to meet targets and timelines.
  • Perform independent internal and external audits for adherence to cGMPs and other relevant Federal, foreign and corporate regulations and policies.
  • Follow up on audit response and corrective actions.
  • Review data, records and documents to assess appropriateness of investigation, root cause identification and corrective action activities.
  • Serve as the Quality Compliance representative on cross-functional teams
  • Identify, design, and implement process and system improvements.
  • Evaluate regulatory requirement changes, impact to company's operations and make recommendations to management.
  • Support client audit and regulatory inspection (FDA and Foreign) activities.
  • Serve as a technical subject matter expert (SME) in support of department functions.
  • Mentor junior personnel serving as a subject matter expert (SME) on Quality systems, processes and issues.
  • Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
  • May conduct investigations related to non-compliance matters.Technical Duties/Responsibilities:
    • Review and approve quality management records.
    • Participate in discrepancy investigations. Ensure discrepancies are thoroughly identified, defined and properly assessed.
    • Participate in company audit readiness activities.
    • Interact with interdepartmental contacts on discrepancy assessment, resolution, and quality approval.
    • Provide guidance to internal and external customers on best practices for maintaining a quality program.
    • Ensure that the proper policies and procedures are in place.
    • Identify, design, and implement process improvements.
    • Provide input into the design and presentation of departmental performance metrics.Qualifications:
      • B.A. or B.S. degree (preferably in Life Science) and at least 5-6 years of experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience
      • Internal and External Audit experience and/or certification is required.
      • Sound knowledge of cGMPs or equivalent regulations
      • Ability to interpret and relate Quality standards for implementation and review
      • Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
      • Ability to communicate clearly and professionally both in writing and verbally
      • Skillful in problem solving and analytical thinking.
      • Flexibility in work hours to meet business objectivesFor Immediate Consideration, Apply Today! Questions? Call Grace at 714.253.7656, Email at grap467@kellyservices.com, or--schedule a time to connect directly follow the link:--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, Tustin , Sr. Specialist, Quality Assurance Compliance, Biologics, Tustin, CA, Other , Tustin, California