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:
- Operate manufacturing machinery as assigned by the immediate supervisor such as “Printing Machine, Amplas etc.
- Assist in the maintenance and adjustment of machinery and mechanical equipment such as; motors, pneumatic equipment, production belts, production machinery and other equipment.
- Perform all tasks with strict observance of cGMP's, cSOP's, cGDP's and other internal and external regulations.
- Able to read and understand the specifications for the product such as dimensions and tolerances as well as understand the operational parameters of the equipment.
- Supply the manufacturing machine with material to maintain production, make foil changes, die change, etc. and comply with the established itinerary.
- Perform preventative maintenance when required.
- Make general repairs to manufacturing machinery; if there is a major problem, the Manufacturing Technician will take responsibility for the matter.
- Fill out the required documentation to comply with all the specifications and procedures (SOP's). Document in record forms of "scrap," downtime, efficiency, etc.
- Responsible for the equipment and tools used to perform daily work.
- Able to read and understand ‘schematics’ and ‘blue prints’, alarms, clocks, PLC and basic electrical concepts.
- Observe mechanical devices in operation; listen to their sounds to locate the cause of the problem.
- Provides support in assigned activities (e.g. extended shifts, weekends, shutdown/slowdown, etc) as necessary.
- Must keep the work area in clean and safe conditions. Follow the 6’s concepts.
Qualifications:
- Technical Certification or Technical Degree with a concentration in General Mechanics or some other technical aspect.
- One (1) year of related experience may be equivalent.
- Able to effectively present information and respond to questions from groups of managers, clients, customers, employees, and internal or external audits.
- Ability to communicate, read, write and understand English/Spanish languages.
- cGMP's Training, license and other trainings, certificates, licenses, exams and registrations that the immediate supervisor refers.
- Must use the proper equipment in any clients area to comply with Company policies, and any internal or external regulation; or policy (e.g. safety shoes, safety glasses, ear plugs, safety gloves, uniform, and any other necessary equipment in order to protect the health and safety of the incumbent.)
- While performing the duties of this job the incumbent must use computer; small precision tools, telephone, office supply, hand tools, electrical tools, etc.
- Availabilty for night shift (10 pm- 6am or 11pm-7am)
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools.
Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
