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Job Description: Job Description: Perform Quality Control testing for in-process, release, stability, and water, in a cGMP environment. It is preferred that the candidate have analytical experience using Waters HPLC, UV-Vis spectrophotometer, AKTA Explorer, and total organic carbon analyzer. The successful candidate will also perform other key activities such as data review, ensuring laboratory cGMP compliance is maintained, execution of technical transfer and co validation activities, instrumentation verification/preventative maintenance, assisting with laboratory investigations, writing procedures and technical documents as required, and providing communication of business critical information to operations and Quality Control management. This is a floating position to cover rotating 12 hour shifts on either days or nights with weekend support. (Days: 6:00am – 6:00pm, Nights 6:00pm-6:00am)
Specific Knowledge, Skills, Abilities, etc: (describe the most critical competencies which are required to perform the job)
- Demonstrate strong theoretical understanding of scientific area of study.
- Demonstrate problem solving ability, interpersonal, oral and written communication skills.
- Ability to prioritize objectives from multiple projects, adheres to scheduled timelines while maintaining flexibility and attention to detail.
- Contribute to a team based, collaborative, and positive environment, clarity of purpose and high commitment to business goals
Education/Experience/ Licenses/Certifications: (list required education and experience, along with any additional education/experience/qualifications that are preferred)
- BS degree in scientific field with minimum of 1 year experience providing support to an on demand testing lab supporting GMP manufacturing OR M.S. degree in scientific field with limited or no experience
- Prefer analytical experience using Waters HPLC, UV-Vis Spectrophotometer, ATKA Explorer, and total organic carbon analyzer.
Physical Demands: (see items to consider on last page)
• Vision (Acuity, color-correction allowed.)
• Reaching (Shoulder)
• Repetitive (Use of Arm, Hands, Wrists)
• Unassisted lifting of items, not to exceed 50 lbs
Work Environment: (see items to consider on last page)
This position is a lab-based position which requires appropriate levels of personal protective equipment (PPE).
This role will require:
• Contact with biohazardous materials such as live cell cultures and other hazardous chemicals including methotrexate, acids, and caustics.
• Powdered materials and high temperature liquids and solids may also need to be handled.
• Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on step-stools, and reaching is required.
• This role also requires frequent unassisted lifting (not to exceed 50 lbs).
• Repetitive use of arms/hands/wrists and grasping is also required.
• Depending on the work demands, office-based work requires sitting.
• This position is based indoors and you will primarily be working with others, but also independently and alone at times.
• This position is a team-based position that requires shift work (12 hour shifts either days or nights), weekends, and holidays.
Additional Job Requirements:
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Axelon Services, Corp is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity, national origin, disability, or protected veteran status.