JT124 - TECHNICIAN III

Quality Consulting Group, LLC; Puerto Rico; Vor Ort; USD 42.000 - 64.000; Vollzeit

Zusammenfassung

QUALITY CONSULTING GROUP, LLC is seeking a Mixing Technician to join its team in Puerto Rico and the USA. The role involves weighing and mixing raw materials, operating mixing equipment, and ensuring compliance with cGMP, cGDP, and CFR standards.

You will maintain production records, perform sampling, and support manufacturing operations in a fast-paced environment, with flexible shifts including weekends and 3rd shift overtime.

Qualifikationen

• Associate's Degree required; Bachelor's Degree preferred.
• 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.
• 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.
• Willingness to work Wednesday-Sunday & overtime -3rd shift position

Aufgaben

• Mixing and weighing of raw materials according to established procedures.
• Operate, start, and adjust mixing machines and valves to achieve required mixing specifications.
• Monitor and maintain automatic mixing equipment.
• Complete, review, and maintain production records and reports accurately.
• Identify documentation errors and ensure compliance with documentation standards.
• 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.

Ausbildung

Associate's Degree

Bachelor's Degree

Jobbeschreibung

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 insterilization operations, manufacturing, mechanical maintenance, or a pharmaceutical/medical device environment.
• Experience operating, loading, and unloadingsterilization vessels/equipment.
• Basic knowledge ofmechanical equipment maintenance, troubleshooting, and repairs.
• Ability to performpreventive and corrective maintenanceon sterilizers and related mechanical equipment.
• Knowledge and understanding ofcGMP, cSOPs, cGDPs, Safety Regulations, and applicable regulatory requirements.
• Ability to followSOPs, safety procedures, and Good Manufacturing Practicesconsistently.
• Ability to work effectively in afast-paced manufacturing environmentand respond to equipment issues in a timely manner.
• Strong attention to detail and commitment toquality, safety, and compliance.
• Ability to work independently as well as effectively within ateam environment.
• Ability to perform physical tasks associated withloading/unloading sterilization equipment and maintaining manufacturing equipment.
• Availability to workflexible shifts, weekends, overtime, or on-call schedules, as required by production needs.
• Willingness to work Wednesday-Sunday & overtime -3rd shift position

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.