Manufacturing Operations Specialist

Katalyst Healthcares & Life Sciences

Durham, NC

JOB DETAILS
SKILLS
Biology, Biotech and Pharmaceutical, Chemistry, Cleaning Equipment, Corrective Action, Documentation, Drug Manufacturing, GMP (Good Manufacturing Practices), Inventory Management, Maintain Compliance, Manufacturing, Manufacturing Equipment, Manufacturing Operations, Manufacturing Systems, Manufacturing/Industrial Processes, Operational Support, Operations Management, Process Improvement, Production Control, Record Keeping, Regulatory Compliance, Standard Operating Procedures (SOP)
LOCATION
Durham, NC
POSTED
1 day ago
Summary:
The Manufacturing Operations Specialist supports pharmaceutical manufacturing activities by operating production equipment, executing batch records, and maintaining compliance with GMP standards while ensuring safe and efficient operations.
Roles & Responsibilities:
  • Operate manufacturing equipment following SOPs and batch records.
  • Execute manufacturing processes in accordance with GMP requirements.
  • Complete electronic batch documentation accurately.
  • Perform equipment cleaning and changeovers.
  • Monitor production processes and identify abnormalities.
  • Support deviation investigations and corrective actions.
  • Maintain inventory of manufacturing supplies.
  • Participate in shift handoffs and production meetings.
  • Follow all safety and environmental procedures.
  • Support continuous process improvement initiatives.

Requirements:

  • 2 4 years of pharmaceutical or biotechnology manufacturing experience.
  • Experience working in GMP-regulated facilities.
  • Familiarity with electronic batch records and manufacturing systems.
  • Experience operating automated manufacturing equipment.
  • Associate or bachelor's degree in biology, Biotechnology, Chemistry, or related field.

About the Company

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Katalyst Healthcares & Life Sciences