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 under general supervision.
- Maintain accurate records and logs in accordance with FDA regulations, Good Manufacturing Practices (GMP), and ISO 9000 standards.
- Work effectively in a team setting, supporting team goals and objectives.
- Make effective decisions relative to position requirements while following instructions and standard practices.
- Follow standard operating procedures (SOPs) and operate a variety of 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 minor equipment repairs and assist with root‑cause analysis for process or product exceptions.
- Monitor quality using statistical process control or other control procedures and ensure accurate documentation of quality, safety, and maintenance records.
- Identify, troubleshoot, and resolve basic issues related to machine performance or product quality.
- Follow all client housekeeping, safety, and GMP policies and procedures.
- Work flexible and/or extended hours, including overtime as required to meet business needs.
Qualifications
- High school diploma or equivalent.
- One to two years of relevant experience.
- Developed basic skills, techniques, and procedures within a specific process or method.
- Effective communication skills understandable to co‑workers and supervisors.
- Ability to read, write, interpret, and comprehend specifications in English and perform basic math calculations.
- Ability to work flexible, extended, and overtime 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 procedures and client safety policies.