Pharmaceutical Manufacturer - South Bend, United States - Spectronrx
Description
_Pharmaceutical Manufacturing Specialist _Manufacturing Specialist
SpectronRx has a great opportunity for a Production Specialist.
You will be responsible for process manufacturing of radiopharmaceutical products, preparation of production materials, supplies, general production equipment maintenance and quality control of products as part of a dynamic and awesome Production and Quality Control team.
Duties and responsibilities include:
- Carries out production responsibilities to meet manufacturing schedules.
- Performs chemistry manipulations for production in a GMP environment.
- Ensure regulatory compliance of production protocols within the manufacturing operations.
- Analytical methods and procedures for testing of GMP manufactured radiopharmaceutical products.
- Optimize and validate methods and procedures for radiopharmaceutical products.
- Assist with creating SOP's for use in production.
- Prepare and submit required reports.
- Assist with the preparation of regulatory submissions.
- Supporting and executing deviation reports, OOS, root cause investigations, and CAPA.
- Assist with general lab cleaning, supplies and maintenance.
Qualified applicants will have:
- A Bachelor's Degree in Chemistry, Biochemistry, Chemical Engineering or a related field. An Associates' Degree in these areas, along with a minimum of 3 years of related experience in a pharmaceutical manufacturing environment (with preference to radiopharmaceuticals) maybe considered.
- Prior experience in pharmaceuticals, preferably in a quality or production position is ideal. Prior experience in a radiopharmaceutical environment a plus.
- Aseptic processing experience preferred.
- Excellent communication, analytical, computer/pc and technical writing skills.
- The ability to handle responsibilities in a fast paced manufacturing environment.
- Great attention to detail, and excellent communication skills.
- Demonstrated ability to work as part of a team.
Pay:
$ $32.00 per hour
Benefits:
- 401(k)
- 401(k)
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 10 hour shift
- 12 hour shift
- 8 hour shift
- Holidays
- Monday to Friday
- Night shift
- Weekends as needed
Education:
- Associate (preferred)
Experience:
- Manufacturing: 2 years (preferred)
- CGMP: 1 year (preferred)
Work Location:
In person
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