"Alerted.org

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:

+ Performing advanced installation, troubleshooting, maintenance, repair, testing, and documentation/logs of a wide variety of office utility and facility equipment used in manufacturing, utility plants, analytical labs, and office areas.

+ Developing, writing, and completing various quality systems and safety documentation such as: Standard Operating Procedures (SOP), Change Control (CCMS), Non-Conformance (NC), Work Orders (WO), Job Plans (JP), Hazard Risk Assessments (HRA), Job Hazard Assessments (JHA), etc.

+ Responsible for various aspects of building, utility and production systems/equipment.

+ All work must be completed in a safe (in accordance to HRA, JHA, etc), timely manner according to planning and predefined schedules with minimal impact to production while complying with Good Manufacturing Practices (GMP), SOP, Code of Federal Regulations (CFR) and procedures.

+ Interacts with peers and clients in manufacturing, maintenance, utility plants, analytical labs and contracted services.

+ Provides training for staff, clients and projects, audit support, reviews and technically approves maintenance reports, forms, plans and records, develops, revises, and reviews equipment, maintenance or other related procedures.

+ Interpret and revise loops sheets, electrical schematics, P&ID's, I/O wiring and panel drawings.

+ Reconciles components and products and calculate product exposure to room temperatures.

Qualifications:

+ Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience

+ Filling and finishing manufacturing experience (preferably vial inspection)

+ Basic GMP knowledge

+  Required to know, comprehend, and apply packaging configurations, as well as understand, follow and document batch records for the inspection and packaging process.

+ Hands on maintenance tech experience

+ Experience performing advanced installation, troubleshooting, maintenance, repair, testing, and documentation/logs of a wide variety of office utility and facility equipment used in manufacturing, utility plants, analytical labs, and office areas.

+ Proficient with utilizing Blue Cielo and PI Vision for maintenance applications and general data gathering.

+ Knowledge in Maximo, BMS, and DeltaV systems for daily tasks.

+ Work with system owners and management has provided training on work orders, contacting and receiving from CI, and researching part information to perform tasks.

+ Shift: 3rd shift starting 6:30pm – 7:30am (Thu – Sat), and alternating Wednesday.

+ Expected 12-hour shift

+ Schedule during the initial on-boarding/training phase (2-6 weeks) starting approximately 8:00am to 5:00pm (Mon - Fri)

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.

Powered by JazzHR