Production Operator I

Katalyst CRO; Sparks Corner (MD); On-site; USD 42,000 - 56,000; Full time

Job summary

Katalyst CRO in Sparks, MD is seeking a Production Operator I to support daily manufacturing and packaging in a regulated environment. You will operate equipment, perform assembly, and maintain production records.

This role requires following GMP, FDA, and ISO guidelines, attention to detail, and strong teamwork. Flexible schedules and overtime may be required.

High school diploma or GED is required; 12 years of related experience preferred.

Qualifications

• High School Diploma, GED, or equivalent required.
• 12 years of experience in manufacturing, production, assembly, packaging, warehouse, or related environment preferred.
• Follow written and verbal instructions and work independently on routine assignments.
• Basic math, reading, and documentation skills.
• Strong attention to detail and commitment to quality.
• Effective communication and teamwork skills.
• Flexibility for overtime and additional hours when required.
• Dependable attendance and punctuality essential.
• Comfortable in a fast-paced production environment with changing priorities.

Responsibilities

• Perform production activities such as assembly, packaging, labeling, inspection, and material handling.
• Operate and monitor production equipment according to established procedures.
• Complete manufacturing documentation and production records accurately and timely.
• Follow quality, safety, and compliance requirements, including GMP, FDA, and ISO guidelines.
• Inspect products for quality and report defects, discrepancies, or equipment issues.
• Support team objectives by collaborating with coworkers and supervisors.
• Maintain a clean and organized work area per company standards.
• Adhere to standard operating procedures and work instructions while meeting productivity targets.
• Assist with changeovers, setup activities, and other production support functions as needed.
• Rotate between workstations and tasks based on operational requirements.
• Foster effective teamwork and communication across shifts.

Skills

Attention to detail

Communication

Teamwork

Adaptability

Documentation skills

Education

High School Diploma / GED

Job description

Job Summary

The Production Operator I is responsible for supporting daily manufacturing and packaging operations in a regulated production environment. This role involves operating equipment, performing assembly and packaging activities, maintaining production records, and ensuring compliance with quality and safety standards.

Job Summary

The Production Operator I is responsible for supporting daily manufacturing and packaging operations in a regulated production environment. This role involves operating equipment, performing assembly and packaging activities, maintaining production records, and ensuring compliance with quality and safety standards.

Key Responsibilities

• Perform production activities such as assembly, packaging, labeling, inspection, and material handling.
• Operate and monitor production equipment according to established procedures.
• Complete manufacturing documentation and production records accurately and in a timely manner.
• Follow quality, safety, and compliance requirements, including GMP, FDA, and ISO guidelines.
• Inspect products for quality and report any defects, discrepancies, or equipment issues.
• Support team objectives by collaborating effectively with coworkers and supervisors.
• Maintain a clean and organized work area in accordance with company standards.
• Adhere to standard operating procedures and work instructions while meeting productivity targets.
• Assist with changeovers, setup activities, and other production support functions as needed.
• Rotate between workstations and tasks based on operational requirements.
• Qualifications
• High School Diploma, GED, or equivalent required.
• 12 years of experience in manufacturing, production, assembly, packaging, warehouse, or a related environment preferred.
• Ability to follow written and verbal instructions and work independently on routine assignments.
• Basic math, reading, and documentation skills.
• Strong attention to detail and commitment to quality.
• Effective communication and teamwork skills.
• Ability to work flexible schedules, overtime, and additional hours when required.
• Dependable attendance and punctuality are essential.
• Comfortable working in a fast-paced production environment and adapting to changing priorities.

Preferred Skills

• Experience working in FDA-regulated, GMP, ISO, pharmaceutical, medical device, or manufacturing environments.
• Familiarity with production documentation and quality inspection processes.
• Ability to learn new equipment and processes quickly.
• Strong problem-solving and organizational skills.