Operator 2, Machine
Katalyst CRO · Hunt Valley, MD · Yesterday
On-siteManagementContract
Responsibilities
- Perform routine production functions including filling, utility operations, packing, packaging, assembling, labeling, and inspecting.
- Maintain accurate records and logs in accordance with FDA, GMP, and ISO 9000 requirements.
- Work within standards and operating procedures to plan, perform, and make decisions regarding the set‑up and operation of various production equipment, including automated machine processes and controls.
- Use independent judgment to troubleshoot and solve problems under general supervision.
- Perform clean‑up functions in sterilized areas as needed.
- Identify the need for minor equipment repairs.
- Analyze and evaluate charts, follow simple diagrams, testing, and inspecting procedures.
- Assist with root‑cause analysis activities for process or product exceptions.
- Monitor quality in accordance with statistical process or other control procedures.
- Ensure accurate documentation of all relevant quality, safety, and maintenance records.
- Identify, troubleshoot, and resolve basic issues associated with machine performance or product quality.
- Demonstrate the ability to follow established Good Manufacturing Practices (GMP) procedures.
- Follow all client housekeeping and safety policies and procedures.
- Work overtime as required to meet client business requirements.
Qualifications
- High school diploma or equivalent.
- One to two years of relevant experience.
- Develops skills in basic tasks, techniques, and procedures within a single skill area, process, or method.
- Applies basic knowledge and skills to complete routine tasks consisting of prescribed steps.
Skills
- Effective communication skills that are understandable to co‑workers and Team Lead/Supervisor.
- Ability to read, write, interpret, and comprehend specifications written in English.
- Proficiency in basic math calculations.
- Ability to work flexible and/or extended hours and report to work regularly and punctually.
- Strong teamwork orientation and ability to get along with people.
- Willingness to rotate into different tasks and responsibilities.
- Capability to follow established GMP, housekeeping, and safety procedures.