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Quaity Assurance Auditor I - Labs

Company: Pharmaceutical Product Development, LLC
Location: Richmond
Posted on: September 22, 2022

Job Description:

Department: Quality Assurance, supporting Chromatography Location: Richmond, VA - flex - a combination of office based and remote work PPD clinical research services, Thermo Fisher's clinical research business,is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD - Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

As a QA Auditor I you will assure the quality of lab data and reports.

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

  • Assures the quality of lab data and reports.
  • Conducts internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations.
  • Identifies and addresses non-conformance issues.
  • Assists in the delivery of quality services for contracted quality assurance audits, internal site audits, laboratory audits and file audits for clients and projects.
  • Applies company policies and procedures to resolve routine issues.
    Essential Functions:
    • Audits laboratory data for compliance with methods and standard operating procedures and report findings
    • Audits sample result tables and analytical reports for completeness and accurate representation of the data and report findings
    • Serves as a resource to operational departments on audit or quality assurance subject matter
    • Assists in the preparation of audit findings and/or other related information #HP-CRGQA #LI-AP1 Job Qualification Education and Experience:
      • Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associates' degree and relevant experience is acceptable in lieu of Bachelor's degree
      • Previous QA or lab experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years') or equivalent combination of education, training, & experience.
      • Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job.
        Knowledge, Skills and Abilities:
        • Familiar with applicable GxP and appropriate regional regulations (e.g., FDA and other regulatory agency guidelines)
        • Thorough working knowledge of SOPs and WPDs
        • Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
        • Strong attention to detail
        • Able to work independently or in a team environment
        • Good problem-solving abilities
        • Good organizational and time management skills
        • Basic computer skills and ability to learn and become proficient with appropriate software
        • Proven flexibility and adaptability Working Environment:
          PPD clinical research servicesvalues the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
          • Able to communicate, receive, and understand information and ideaswith diverse groups of peoplein a comprehensible and reasonable manner.
          • Ableto work upright and stationary and/or standingfor typical working hours.
          • Able to lift and move objects up to 25 pounds
          • Able to work in non-traditional work environments.
          • Able to use and learn standard office equipment and technologywith proficiency.
          • May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
          • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. Our 4i Values: Integrity - Innovation - Intensity - Involvement If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application - we'd love to hear from you! Diversity Statement PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group. --- All U.S. colleagues are required to report vaccination status. New hires will be asked to report vaccination status within the first two weeks of employment.

            --- All U.S. new hires who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), remote site monitors-local (RSM-L) all CRA and RSM-L line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. New hires will be asked to disclose vaccination status upon first day of employment and are required to report vaccination status within first two weeks of employment.

Keywords: Pharmaceutical Product Development, LLC, Richmond , Quaity Assurance Auditor I - Labs, Accounting, Auditing , Richmond, California

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