QC Reviewer - Manufacturing / GMP

Work Schedule
Second Shift (Afternoons)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards

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.

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Key responsibilities:

The QC Data Reviewer supports the data review team within a fast paced GMP environment in support of one or more of the following areas; raw material, environmental monitoring, in-process, final bulk, stability or validation. The coordinator will complete review of assays, data mining projects, and archiving of data. Works under the guidance of a supervisor but is able to manage time efficiently in achieving timely completion of assigned duties

Available Schedules:

• (Mon-Fri second shift: 2:00pm-10:30 pm)

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years')
• OR Masters degree

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:

• 2+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry.
• Archiving of data in the RIMS system
• Performs Routine Review of Lab test data including On-the-Floor Review, and Off-the-Floor Review for low complexity test methods.
• Understands and maintains a safe work environment for themselves and others in accordance with procedural requirements
• Understand, implements and maintains GMP with respect to laboratory records, procedures and systems in accordance with procedural requirements
• Accepts responsibility to complete assigned tasks as committed. Works with other to maintain a positive atmosphere to accomplish business objectives
• Supports the review team with administrative tasks such as logbook management and scanning/filing of data.
• Participates in training of other employees, but focused on demonstration and not management of training delivery

Working Environment:

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 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.