GMP Manufacturing Ops Specialist – Sterilization & QA

Katalyst CRO; Sparks Corner (MD); On-site; USD 42,000 - 66,000; Full time

Job summary

Katalyst CRO is seeking a Laboratory Operations Associate to manufacture and assemble clinical and commercial products and operate production equipment. The role requires careful weighing and measuring of materials to ensure batch integrity, plus participation in in-process testing to validate specifications.

The position emphasizes adherence to GMP, proper disposal of waste chemicals, and the ability to follow established procedures. Overtime may be required to meet client needs.

Qualifications

• High school with technical certification in laboratory operations plus 3 years laboratory experience.
• AS degree in a scientific discipline with 2-3 years laboratory experience.
• BS degree in a scientific discipline plus 1-2 years laboratory experience.

Responsibilities

• Manufacture and assemble clinical and commercial products; operate production equipment.
• Weigh, measure, and check raw materials to ensure batches contain proper ingredients and quantities.
• Assist with in-process testing to ensure batches meet specifications.
• Validate processes and equipment related to filtration, cleaning and sterilization.
• Remove and dispose of waste chemicals, solvents and acids.
• Provide training support for onboarding and new procedures.
• Support lead/supervisor and propose continuous improvement ideas.
• Follow GMP procedures and Client safety/housekeeping policies.
• Be able to work overtime as required to meet business needs.

Skills

Teamwork

Communication

Detail-oriented

Time management

Independent work

English proficiency

MS Excel

Education

High School with technical certification in laboratory operations

AS degree in a scientific discipline

BS degree in a scientific discipline

Tools

MS Excel

Job description

Katalyst CRO is seeking a Laboratory Operations Associate to manufacture and assemble clinical and commercial products and operate production equipment. The role requires careful weighing and measuring of materials to ensure batch integrity, plus participation in in-process testing to validate specifications.

The position emphasizes adherence to GMP, proper disposal of waste chemicals, and the ability to follow established procedures. Overtime may be required to meet client needs.