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
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
- Sunday through Thursday, or Sunday through Friday with one day off during the week, depending on business needs
- Shift C- 3rd shift