Quality Assurance Auditor II

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

Job Description:

Department: Quality Assurance, supporting Chromatography Location: Richmond, VA - flex based, combination of office 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 life cycle 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 clinical research services , where science is our passion, quality is our commitment and people are the cornerstone of our success. As a QA Auditor II, you will conduct complex internal and external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and client contractual obligations. 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 well-being of our employees. Summarized Purpose:

• Conducts complex internal and/or external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations.
• Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues.
• May perform technical document review and other GxP practice activities in support of clinical development programs.
• Provides audit reports to management.
• Plans and delivers quality services for contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects. Essential Functions: Conducts and/or leads a variety of client, internal or GxP audits and regulatory inspections as requested by senior management Performs directed site audits, facility, vendor and/or sub-contractor audits Provides GxP consultation and support to PPD project teams and external clients Leads process audits and may participate as a co-auditor in more complex system audits Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement) Serves as a resources to operational departments on audit or quality assurance subject matter Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings #LI-AP1 #HP-CRGQA Job Qualification Education and Experience:
  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification (life science degree preferred)
  • Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years') or equivalent combination of education, training, & experience. Successful completion of PPD Foundation Training.
  • 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:
    • Thorough knowledge of GxP and appropriate regional research regulations and guidelines
    • Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management
    • Excellent oral and written communication skills
    • Strong problem solving, risk assessment and impact analysis abilities
    • Solid experience in root cause analysis
    • Above average negotiation and conflict management skills
    • Flexible and able to multi-task and prioritize competing demands/work load PPD clinical research servicesvalues the health and well-being 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 , Quality Assurance Auditor II, Accounting, Auditing , Richmond, California