Production Operator I - GMP/Quality Focus

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

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.