Facilities and Utilities Quality and Compliance Specialist (Contractor) – Gurabo, PR

General requirements education & experience

Quality Assurance Specialist with background in quality assurance requirements for a Pharmaceutical/Medical Devices Manufacturing facility from a utilities operations and maintenance perspective.  Must have a 4-year degree preferably in science or technical discipline. Must have 3 years of experience, 5 years of experience in area is a plus. Areas of responsibilities are Program Management/ Operations, Reporting, People Management, and others.

Elements & Tasks

  • Support programs to create value for client to ensure program deliveries meet or exceed expectations.
  • Build successful relationships within the compliance, utilities operation, engineering, and other client personnel to promote confidence, forward planning, and best practices.
  • Collaborate with account wide team and proactively share and reapply all learnings, successes and best practices.
  • Manage quality investigations, CAPAs, non- conformances and audit observations tasks required to support the maintenance of Facilities and Utilities operations.
  • Expected to interface with the client’s quality personnel to ensure that all of the client’s SOPs are followed, including GDP, Investigations and CAPA’s, audits. Work performed by the team is documented and recorded in the proper fashion.
  • Sustain quality assurance support and support the implementation of the Quality and Compliance program for a state-of-the-art pharmaceutical/ medical devices manufacturing facility as it relates to the facilities maintenance of this plant.
  • Report on critical & key performance measurements.
  • Submit periodic task reports to management.
  • Mentor, develop and train peer and other team members.
  • Provides direction/information to vendors, facilities staff and service providers as required to ensure that quality assurance expectations are communicated and followed.
  • Any and all other duties and tasks assigned.

Skills & Knowledge

  • Strong background in technical documentation
  • Work independently and within a team
  • Communicate effectively with technical, quality assurance and other personnel.
  • Proficient in Microsoft Office Suite programs Word, Excel and QMS System such as Trackwise
  • Ability to investigate, recognize and diagnose trends and patterns.
  • Experience with Root Cause Analysis and tools
  • General understanding of cGMP’s as they relate to the performance of maintenance and repairs to facilities, utilities and equipment utilized for the manufacturing of drug products.
  • Experience working at an FDA regulated manufacturing facility in a quality assurance or quality control capacity.
  • Understanding of FDA regulations including 210 CFR part 210 and 211.
  • Strong commitment to quality assurance, and a willingness to help develop a quality first culture on the Site.
  • Knowledge of Quality Engineering techniques, CMMS systems, and Quality Management Systems