QA Specialist

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)

Discover Impactful Work:

Provides expertise to the department in one or more specialized areas, such as root cause analysis, corrective action/preventive action, batch record review, specialized laboratory testing, Total Quality Management (TQM), or other specialized areas/processes in the execution of the Quality Management System (QMS), which may include the performance of internal and/or vendor audits, participation in client or regulatory audits, required documentation review/approval, tracking of investigations, deviations or audit responses, the management of corrective and preventive (CAPA) action plans that result, and attendance at inter-departmental meetings related to the area of expertise. 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 subject matter expert for process/vendor audits or activities in area of expertise, e.g. reviews manufacturing investigations, lab investigations, root cause analysis, batch record review or Total Quality Management.• 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.• Reviews batch records and associated documentation for completeness and accuracy of data.• Utilizes department checklists to evaluate content of reports and compliance with reporting criteria.• Verifies accuracy of analytical results and sample identification; inventories and submits data to archives. Provides support for quality investigations and contracted services.• Handles production pre and post line clearances and in-process checks as per GMP requirements.• Provides support to the department with incoming material inspection as per GMP requirements.• Participates in risk assessments.• Manages set up and filing of documents.• May mentor junior team members in area(s) of expertise.

Keys to Success:

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: • Identified expertise in one or more specialized areas relevant to QA activities, e.g. batch record review, root cause analysis, TQM• May require knowledge of QP Release activities• Knowledge of GxP and appropriate regional regulations and guidelines• Working knowledge of project based or internal GxP audits and vendor audits• Excellent oral and written communication skills• Strong problem solving, risk assessment and impact analysis abilities• Experience in root cause analysis and CAPA management• Ability to remain flexible and prioritize competing demands/work load• Ability to multitask whilst still delivering high quality results

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

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 1-855-471-2255*. 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