Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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.

• Conducts a variety of client, internal or GxP audits and supports regulator inspections as requested by senior management
• Participates in process audits
• Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample result tables, facility audits, 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

• 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 1-2 years')

• Familiar with applicable GxP and appropriate regional regulations
• Demonstrated ability to perform GxP audits based on SOPs and applicable FDA regulations, ICH guidelines and to all other standards or guidelines applicable to business-related requirements
• Demonstrated ability to independently review study documents for compliance with regulatory requirements or organization's procedures (e.g. informed consents, protocols, CRFs, source document templates, method validations, equipment qualifications)
• Achieves acceptable standards of quality and meets timelines for QA deliverables and required departmental reports
• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
• Very good problem solving, risk assessment and impact analysis abilities
• Proficient at negotiation and conflict management
• Flexible and able to multi-task and prioritize competing demands/work load
• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

• 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 and/or standing for 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 technology with 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.