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Scientist, QC - Bloomington Indiana
Company: Disability Solutions Location: Bloomington, Indiana
Posted On: 05/17/2024
We're hiring for a Scientist, QC to support the microbiology team in Bloomington, Indiana!Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.--Catalent is committed to a Patient First culture through excellence in quality and--compliance, and to the safety of every patient, consumer, and Catalent employee.--Catalent Biologics in Bloomington, Indiana--is a--state-of-the art,--GMP--manufacturing--facility,--providing--one million--sq/ft of drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives.The Scientist, QC will perform microbiology testing such as, microbial enumeration testing and endotoxin testing, data analysis, document writing, and data reporting to support the manufacturing and release of bulk drug substance and drug product. This is a full-time, salaried position and is 100% site based. The schedule is Monday - Friday, 1st shift.The Role - Independently executes and properly documents cGMP Quality Control testing.
- Independently operates basic and moderately complex cGMP Quality Control equipment.
- Assists in authoring technical documents such as SOPs and reports.
- Coordinates with Supervisor to prioritize and schedule activities to meet deadlines.
- Supports continuous process improvement initiatives.
- Supports training of specific analytical techniques.
- Performs self-review of analytical data for accuracy and consistency with SOP.
- Enters data into Laboratory Information Management System (LIMS) or laboratory reports.
- Performs general lab housekeeping in adherence to 5S standards.
- Initiates and assists with records in TrackWise.The Candidate
- Educational Requirements:
- Bachelor's degree in science field with 3-5 years of experience, including 1-year GMP experience, or regulated industry.
- Master's degree in science field with 0-2 years of experience, including 1-year GMP experience, or regulated industry.
- PhD in science field with 0-2 years of experience, GMP experience preferred or other regulated industry.
- General laboratory equipment experience, including micropipettes.
- Must be able to read and understand English-written job instructions and safety requirements.
- Preferred Qualifications:
- Strong understanding of analytical chemistry and moderately complex lab equipment.
- Experience maintaining and troubleshooting Quality Control equipment.
- Familiarity with clean room procedure, aseptic technique, and general lab equipment experience.
- cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP) knowledge.
- Experience following standard operating procedures (SOP).Why you should join Catalent
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