QA Auditor I

About the role

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.

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.

Responsibilities

Conducts a variety of client, internal or GxP audits and supports regulatory inspections as requested by senior management. Participates in process audits and performs other types of QA audits or activities. 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.

• Conducts a variety of client, internal or GxP audits
• Supports regulatory 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 results tables, facility audits, process improvement)

Requirements

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). 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.

• Bachelor's degree or equivalent
• Relevant formal academic / vocational qualification
• Previous QA experience (comparable to 1-2 years)

Skills

• 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
• 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/workload

Working Conditions and Environment

Work is performed in an office/ laboratory and/or a clinical environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Personal protective equipment required such as protective eyewear, garments and gloves.

• Office/ laboratory and/or a clinical environment
• Exposure to biological fluids with potential exposure to infectious organisms
• Exposure to electrical office equipment
• Personal protective equipment required

Physical Requirements

Ability to work in an upright and /or stationary position for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Ability to work in an upright and /or stationary position for 6-8 hours per day
• Repetitive hand movement of both hands
• Frequent mobility required
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
• Light to moderate lifting and carrying (or otherwise moves) objects with a maximum lift of 15-20 lbs