Operator 2, Machine

Katalyst CRO; Cockeysville (MD); On-site; USD 25,000 - 39,000; Full time

Job summary

Katalyst CRO is seeking a production operator in Maryland to perform routine filling, packing, assembling and labeling under supervision. You will maintain accurate records in line with FDA, GMP and ISO9000 standards, and work as part of a team to meet quality and efficiency goals.

The role requires a high school diploma or equivalent, 1–2 years of related experience, and availability to work flexible hours including overtime.

Qualifications

• High school diploma or equivalent.
• Ability to read, write, and comprehend English specifications.
• Ability to perform basic math calculations.
• Willingness to work overtime and flexible hours.

Responsibilities

• Perform routine production functions including filling, packing, assembling, labelling and inspecting under supervision.
• Maintain accurate records and logs per FDA, GMP, and ISO9000 requirements.
• Work in a team setting and support team goals and objectives.
• Follow SOPs and safety policies; identify and report equipment or process issues.

Education

High School Diploma or equivalent

1-2 years experience

Job description

• Performs routine production functions including filling, utility operations, packing, packaging, assembling, labelling and inspecting under general supervision. Maintains accurate records and logs in accordance with FDA (Food and Drug Administration), GMPs (Good Manufacturing Practices) and ISO9000 (International Organization for Standardization).
• Effectively works in a team setting, supporting team goals and objectives.
• Makes effective decisions relative to position requirements.
• Must follow instructions and work within routine, standard practices, making decisions as required. Works under direct supervision, following standard operating procedures.
• High school diploma or equivalent. One to two years' experience.
• Develops skills in basic tasks, techniques and procedures within one skill area / process / method.
• Applies basic knowledge and skills to complete routine tasks consisting of prescribed steps.
• Effective communication skills at a level co-workers and Team Lead/Supervisor can understand.
• Ability to read, write, interpret, and comprehend specifications written in English and perform basic math calculations.
• Must be able to work flexible and/or extended hours and report to work on a regular, punctual basis.
• Ability to get along with people and be able to work in a team environment.
• Willingness to rotate into different tasks and responsibilities.
• Works within standards and operating procedures to plan, perform, and make decisions regarding the set up and operations of a variety of production equipment, including automated machine processes and controls to perform routine assembly-line production functions of filling, packing, assembling, labelling and inspecting
• Uses independent judgment in troubleshooting and problem solving under general supervision
• May perform clean up functions in sterilized areas
• Identifies the need for minor equipment repairs
• May analyse and evaluate charts, follows simple diagrams, testing, and inspecting procedures
• Assists with root-cause analysis activities for process or product exceptions
• May monitor quality in accordance with statistical process or other control procedures.
• Ensures accurate documentation of all relevant quality, safety, and maintenance documents. Identifies, troubleshoots, and resolves basic issues associated with the machine performance and/or product quality.
• Demonstrates the ability to follow established procedures according to Good Manufacturing Practices (GMP).
• Must follow all client's housekeeping policies and procedures.
• Must follow all client's safety policies and procedures.
• Must be able to work overtime as required to meet Client business requirements.