Shire Jobs

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:

• Responsible for 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

• 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 Clients procedures. This role interacts with peers and clients in manufacturing, maintenance, utility plants, analytical labs and contracted services.

• Provide 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

• Routinely perform moderately-complex to complex processes according to Standard Operating Procedure (SOP).

• Specific responsibilities include inspection and packaging of product-filled vials per procedures and batch records.

• Reconcile components and products, and calculate product exposure to room temperatures;

Qualifications:

• Associate degree in related area

• 4 years of related experience

• Troubleshooting System experience

• Filling and finishing manufacturing experience, preferably vial inspection

• Understanding of measurements, calculations and the metric system

• 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.

• 12-hour shift (6:30PM-7:30AM), Thursday through Saturday, and alternating Wednesdays.

• The schedule during the initial on-boarding/training phase (2-6 weeks) will be Monday through Friday, approximately 8am to 5pm

  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.

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