Senior Scientist I, QC - Method Validation
Catalent
- Madison, WI
- Permanent
- Full-time
- Independently executes and properly documents cGMP Quality Control Methods and testing.
- Authors technical documents such as SOPs and reports.
- Interacts as an SME for internal and external customers.
- Supports training of specific analytical techniques.
- Enters data into Laboratory Information Management System (LIMS) or laboratory reports.
- Performs general lab housekeeping in adherence to 5S standards.
- Initiates and leads investigations or deviations in Trackwise.
- Performs self-review of analytical data and technical review of peers' analytical data for accuracy and consistency with SOP’s.
- Actively participates in team meetings and/or training sessions.
- Other duties as assigned.
- PhD Degree in Biology, Biotechnology, Chemistry or related life sciences field; OR
- Master’s Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 4 years of industry experience; OR
- Bachelor’s Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 6 years of industry experience; OR
- Associate Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 10 years of industry experience; OR
- High School Diploma or equivalent with a minimum of 11 years of industry experience
- Experience writing technical documents.
- Familiarity with clean room procedure, aseptic technique, and general lab equipment experience.
- cGMP, Good Documentation Practices (GDP) or Good Laboratory Practices (GLP) knowledge experience.
- HPLC, CE experience required, (icIEF) strongly preferred.
- Strong understanding of analytical chemistry and simple, moderately complex, and complex lab equipment.
- Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.
- Occasional stooping, kneeling, crouching, bending, carrying, grasping.
- Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.
- Must comply with EHS responsibilities for the position.
- Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures must be followed to minimize exposure, including proper use of PPE (personal protective equipment) and clean room gowning.
- Working conditions will be Heating Ventilation and Air Conditioned controlled.
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 152 hours of paid time off annually + 8 paid holidays
- Competitive salary with yearly bonus potential
- Community engagement and green initiatives
- Generous 401K match and Paid Time Off accrual
- Medical, dental and vision benefits effective day one of employment
- Tuition Reimbursement