Compliance Specialist IV, Facilities TEMP

Data Management: Engineering & Maintenance Services
Location: Smithfield RI
Job Code: 929

Job Summary

This position will serve as a point of contact for all Facilities and Logistics Change Controls, Deviations, Investigations, and CAPAs. This individual will work closely with various Facilities and Logistics personnel to assist in the preparation of clearly written documents for review, and represent Facilities during collaborations with QA and other department representatives to obtain understanding and approval for these Facilities and Logistics generated records.

The individual in this position will facilitate and/or perform data verification and data audits for Facilities and Logistics support activities related to work orders, preventive maintenance, technical reports, material certifications, and quarterly Facilities and Logistics metrics.

Principal Responsibilities

• Write and/ or review Facilities and Logistics deviation, investigation, Standard Operating Procedures and CAPA records.
• Represent Facilities and Logistics Micro at cross-functional meetings and report to Facilities and Logistics management on items / topics impacting Facilities and Logistics.
• Facilitate and track the approval and implementation process for all Facilities and Logistics Change Controls and assigned tasks through approval
• Work closely with QA counterparts representing Facilities and Logistics on all quality system and compliance issues, including but not limited to Change Control, deviations, investigations, training and CAPAs
• Design and maintain tracking tools to monitor Facilities and Logistics commitments and assignments related to compliance and quality systems including internal and external audit observations/recommendations.
• Perform review and audit of Facilities and Logistics procedures for consistency and compliance; make recommendations to Facilities and Logistics managers for harmonization and improvement of procedures and practices to maintain compliance

• The individual in this position is expected to have experience and an in depth understanding of manufacturing operations and Quality Systems for pharmaceutical manufacturing environment, including but not limited to, equipment OOS, deviations, CAPAs, root cause analysis, data integrity, training and good documentation practices
• Experience with health authorities guidelines and regulations as they relate to Facilities and Logistics, including work orders, preventive maintenance and calibrations, and general industry best practices.
• The individual in this position will be able to organize his/her own work on a routine basis and requires minimal supervision. The individual must be able to provide updates and tracking on his/her tasks.

• BS degree, with 5-8 years of relevant GMP experience; experience with technical writing related to deviations, investigations and Standard Operating Procedures.