Work ScheduleStandard (Mon-Fri)Environmental ConditionsAble to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob DescriptionThermo Fisher Scientific Inc. is looking for a highly motivated individual to join our team as a QC Scientist I (Data Auditor). In this role, you will have the opportunity to make a significant contribution to meaningful work that has a real-world impact, such as aiding in the search for cancer cures, environmental protection, and food safety. We are a respected company that promotes inclusivity, collaboration, and the pursuit of excellence.Responsibilities:
Verify and process environmental monitoring data
Review and process cGMP testing forms associated with routine testing and batch operations
Adapt to a fast-paced and ever-changing environment based on client or departmental needs
Apply technical writing skills to conduct investigations for out-of-specification samples and deviating events.
Understand and apply aseptic techniques for sterile processing
Report and determine out-of-specification or unexpected results, identifying root causes and proposing solutions
Prepare regulatory documents and communicate with external agencies, clients, and colleagues
Develop and update documentation processes, procedures, and testing forms
Interact directly with clients and provide exceptional customer service
Lead, prepare, and file regulatory documents in support of internal projects
Coordinate and assist in writing SOPs, policy manuals, and instructional documents
Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, ALCOA, Audits, and Safety guidelines
Requirements:
A Bachelor's degree is preferred in a physical science, specifically Chemistry or Biology. An Associate degree in Chemistry or Biology is required.
1-2 years of relevant work experience in performing aseptic techniques, clean room activities, or related experience
Strong problem-solving, interpersonal, communication, presentation, and time management skills
Advanced knowledge of basic instrumental technologies and qualitative and quantitative microbiological analysis
Familiarity with quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs
Proficiency in environmental monitoring sampling procedures
Ability to read, analyze, and interpret technical procedures and governmental regulations
Excellent written and verbal communication skills
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations.Ability to stand, walk, stoop, kneel, crouch periodically.Manipulation (lift, carry, move) of light to medium weights of 10-35-pound pounds.Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time.Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time.Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.Apply today to start your story with Thermo Fisher Scientific: http://jobs.thermofisher.comThermo 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.
