About the role
QUALITY CONSULTING GROUP, a leader in the 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. * Willingness to work Wednesday-Sunday & overtime - 3rd shift position