JT178 - TECHNICIAN III

Quality Consulting Group, LLC; Northern (KY); Hybrid; USD 42,000 - 65,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a Mixing Technician to join our team in a world-class manufacturing environment in the United States. You will weigh and mix raw materials, operate mixing machines, and ensure compliance with cGMP, SOPs, and GDP while maintaining accurate production records.

The role requires an Associate’s degree (Bachelor’s preferred), experience in sterilization operations or pharmaceutical manufacturing, and the ability to work flexible shifts, including weekends or

Qualifications

• Associate's Degree required; Bachelor's degree preferred.
• Experience in sterilization operations and pharmaceutical/medical device environments.
• Experience operating sterilization vessels/equipment.
• Knowledge of cGMP, cSOPs, cGDPs, Safety Regulations.

Responsibilities

• Mix raw materials according to established procedures and SOPs.
• Operate, start, and adjust mixing machines and valves to meet specifications.
• Maintain accurate production records and reports (daily/weekly/monthly).
• Perform weighing of raw materials and assist in sampling activities.
• Ensure compliance with GDP, cGMP, and regulatory requirements.
• Support manufacturing operations in the mixing area as needed.
• Maintain clean, organized work areas and inspect-ready conditions.
• Work collaboratively in a team environment and adapt to shifts.

Skills

Sterilization operations

Mechanical maintenance

Quality compliance

Safety procedures

Education

Associate's Degree

Bachelor's Degree preferred

Tools

Sterilization vessels/equipment

Job description

QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities

• Mixing Technician
• Perform weighing and mixing of raw materials (drugs) such as Amino Acids, Metronidazole, Heparin, Milrinone, and others according to established procedures.
• Perform the hydrolysis process of lactic acid.
• Operate, start, and adjust mixing machines and valves to achieve required mixing specifications.
• Operate auxiliary equipment to prepare mixtures for final processing.
• Monitor and maintain automatic mixing equipment.
• Ensure all weighing and mixing activities comply with SOPs, cGMPs, cGDPs, CFR requirements, and Good Documentation Practices (GDP).
• Complete, review, and maintain production records and reports (daily, weekly, monthly, and annual) accurately.
• Identify documentation errors and ensure compliance with documentation standards.
• Perform manual weighing of raw materials and lift bags weighing up to 100 lbs.
• Apply mathematical skills to accurately weigh and measure materials.
• Coordinate, monitor, and perform sampling activities, referring samples to the Plant Pharmacist as required.
• Conduct routine area audits to ensure compliance with company policies and regulatory requirements.
• Troubleshoot daily quality and material issues to support safe and efficient product release.
• Participate in new product protocols and validation activities.
• Perform drug inventory head counts according to established procedures.
• Support Manufacturing operations in the mixing area as needed.
• Maintain work areas clean, organized, and inspection-ready.
• Work collaboratively in a team environment.
• Perform special projects and additional duties as assigned.
• Work independently with minimal supervision.

Qualifications:

• Associate's Degree required; Bachelor's Degree preferred.
• Previous experience in sterilization operations, manufacturing, mechanical maintenance, or a pharmaceutical/medical device environment.
• Experience operating, loading, and unloading sterilization vessels/equipment.
• Basic knowledge of mechanical equipment maintenance, troubleshooting, and repairs.
• Ability to perform preventive and corrective maintenance on sterilizers and related mechanical equipment.
• Knowledge and understanding of cGMP, cSOPs, cGDPs, Safety Regulations, and applicable regulatory requirements.
• Ability to follow SOPs, safety procedures, and Good Manufacturing Practices consistently.
• Ability to work effectively in a fast-paced manufacturing environment and respond to equipment issues in a timely manner.
• Strong attention to detail and commitment to quality, safety, and compliance.
• Ability to work independently as well as effectively within a team environment.
• Ability to perform physical tasks associated with loading/unloading sterilization equipment and maintaining manufacturing equipment.
• Availability to work flexible shifts, weekends, overtime, or on-call schedules, as required by production needs.
• Sunday through Thursday, or Sunday through Friday with one day off during the week, depending on business needs.
• Shift C- 3rd shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.