Compliance Specialist - Tech Ops (Hybrid location available) 12 month contract
Compliance Specialist - Technical Operations (Automation, Engineering & Facilities) Industry : Biotech Role Summary: The Compliance Specialist, Technical Operations is a member of the Technical Operations Team (Automation, Engineering & Facilities) and is responsible for operations support and compliance related activities for the manufacture of biotech products. Essential Duties and Responsibilities include, but are not limited to, the following: Completes investigations of technical deviations for department issues of non compliance. Ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness. Reviewing and maintaining procedures, polices and other instructional documents with a focus on continuous improvement. Acts as a liaison between Technical Operations and onsite quality and regulatory groups, as well as other departments across the company, with respect to all quality instances and compliance support. Provides support, information, and assistance to individuals, groups and management with the initiation, authorship, review, submission, and follow-up/completion of documents such as Change Controls, risk assessments, impact statements and corrective/preventative action plans. Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, Life Cycle Documents and Engineering Documentation, etc. to assess for compliance with established quality standards, policies and procedures. Review and approval of preventative maintenance records/work orders (corrective and scheduled) on the CMMS system to assess for compliance with established quality standards, policies and procedures. Provide tracking and trending for maintenance of related compliance activities i.e. quality instances and PERs. Maintains knowledge of current good manufacturing practices (cGMPs) and execution of any other GMP compliance related activities as required. Continuous Improvement Implementation. MORE INFORMATION AVAILABLE OVER ON WWW.QARESOURCES.COM