Company

SpectronrxSee more

addressAddressSouth Bend, IN
type Form of workFull-time
salary Salary$24 - $32 an hour

Job 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.

Must be authorized to work in the U.S.

Job Type: Full-time

Pay: $24.00 - $32.00 per hour

Benefits:

  • 401(k)
  • 401(k) matching
  • 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

Benefits

Health savings account, Health insurance, Dental insurance, 401(k), Flexible spending account, Paid time off, Vision insurance, 401(k) matching, Life insurance
Refer code: 8502585. Spectronrx - The previous day - 2024-03-08 18:03

Spectronrx

South Bend, IN
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