GCP QA Auditor II

Company: Thermo Fisher Scientific
Location: Waterbury
Posted on: August 7, 2022

Job Description:

PPD 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 QA Auditor II, you will work remotely and travel to conduct -complex internal and external audits and inspections to ensure compliance with established -quality assurance processes, standards, global regulatory guidelines and client contractual obligations. - -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
• Leads 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 audit.
• Performs other types of QA audits or activities (e.g. database audits, clinical -study report audits, sample results tables, process improvement) -
• Serves as a resource 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 -
• Provides mentorship and guidance to junior auditors -At PPD 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.------ -EDUCATION AND EXPERIENCE:
  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification -
  • Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2+ years) or equivalent combination of education, training, & experience. Successful completion of PPD Foundation Training. -KNOWLEDGE, SKILLS AND ABILITIES:
    • Meets competencies for QA Auditor I plus:
    • 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/workload -
    • Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel--- -
    • Knowledge of 21 CFR 11 compliance is a big plus
    • French as a 2nd language is a plusWORKING ENVIRONMENT:PPD values 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 ideas with diverse groups of people in a comprehensible and reasonable manner. -
      • Able to work upright and stationary for typical working hours. -
      • Ability to use and learn standard office equipment and technology with proficiency. -
      • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. -
      • Up to 50% travel - (Approximately 2 audits per month) - -
      • Employees hired in this role may be assigned to a US government contract and if so would be subject to COVID-19 vaccination and reporting requirementsPPD DEFINING PRINCIPLES:We have a strong will to win - We earn our customer's trust - We are game changers - We do the right thing ----We are one PPD------ -If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you.------ -PPD is an equal opportunity employer.

Keywords: Thermo Fisher Scientific, Waterbury , GCP QA Auditor II, Accounting, Auditing , Waterbury, Connecticut