QA Specialist (Technical Reviewer)

Work Schedule

Other

Environmental Conditions

Office

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 Specialist

Division/ Dept.: Clinical Research Group/ Global Central Labs

Location: Remote (United States)

Summarized Purpose: 

Provides a basic level of expertise to the department in one or more specialized areas or processes in the execution of the Quality Management System (QMS). Will attend inter-departmental meetings related to the area of expertise and provide input. May serve as a QA client contact for company contracted services and contribute to policy-making decisions as a resource in area(s) of expertise. 

A day in the life: 

• Serves as a subject matter expert of the quality event management system i.e., reviews investigations, performs root cause analysis, and assists with CAPA planning.
• Reviews quality event records for accuracy, formatting, consistency and compliance to protocols or SOPs. 
• Participates in client and regulatory inspections/audits, might represent the department, and participates in developing and tracking corrective actions. 
• Provides training for department and/or laboratory staff where required. 
• Utilizes department checklists to evaluate content of reports and compliance with reporting criteria. 
• Provides support for quality investigations and contracted services. 
• Participates in risk assessments. 
• Manages set up and filing of documents. 
• May mentor junior team members in area(s) of expertise. 

Education:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification 

Experience:  

• Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). 
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:  

• Thorough knowledge of applicable GxP and appropriate regional regulations 
• Strong editorial and proofreading skills 
• Firm understanding of central lab services i.e., laboratory testing, biorepository services, study management, etc.
• Good knowledge of SOPs.
• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology) 
• Strong attention to detail 
• Effectively works independently or in a team environment 
• Effective problem solving skills 
• Solid organizational and time management skills including ability to multitask and prioritize competing demands/work load 
• Strong computer skills; ability to learn and become proficient with appropriate software 
• Proven flexibility and adaptability 

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.
• 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.)

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! http://jobs.thermofisher.com

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

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