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QA Auditor I - Labs

Employer
Pharmaceutical Product Development, Inc.
Location
Middleton
Salary
Competitive

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Industry
Technology
Role
Audit / Tax
Job Type
Long-Term
Hours
Full Time
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 a QA Auditor I you will assure the quality of lab data and reports.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 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 findingsAudits sample result tables and analytical reports for completeness and accurate representation of the data and report findingsServes as a resource to operational departments on audit or quality assurance subject matterAssists in the preparation of audit findings and/or other related informationQualifications: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 degreePrevious 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. 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. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.Knowledge, Skills and Abilities:Meets competencies for Associate QA plus:Familiar with applicable GxP and appropriate regional regulations (e.g., FDA and other regulatory agency guidelines)Thorough working knowledge of SOPs and WPDsExcellent oral and written communication skills (including appropriate use of medical and scientific terminology)Strong attention to detailAble to work independently or in a team environmentGood problem-solving abilitiesGood organizational and time management skillsBasic computer skills and ability to learn and become proficient with appropriate softwareProven flexibility and adaptabilityValid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travelWorking 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 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.PPD Defining Principles:- We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPDIf 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.

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