- 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
- 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. Successful completion of PPD Foundation Training.
- 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 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
- 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.
- May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require travel. (Recruiter will provide more details.)
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QA Auditor I - Remote, United States - Thermo Fisher Scientific
Description
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Location/Division Specific Information
Our PPD Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
Title: QA Auditor I - Labs
Division/ Dept.: Clinical Research Group/ GMP Labs
Location: Remote based in WI
Discover Impactful Work:
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.
A day in the life:
Keys to Success:
Education:
Experience:
Knowledge, Skills and Abilities:
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:
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response
