Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job Description

Join Us as a Compliance Specialist - Make an Impact at the Forefront of Innovation! Position overview: The Compliance Specialist executes quality and compliance processes across the organization and facilitates the tracking and reporting of quality and compliance activities. A Day in the Life of a Compliance Specialist: Manages and leads all activities associated with project specific clients, regulatory, vendor, quality management, system, and/or internal audits and investigations to include: Develops updates and disseminates SOP’s/WPD’s as they relate to quality processes. Performs internal and external audit related activities as needed and escalates significant issues appropriately. Continually ensures audit readiness of client files. Contributes to quality process improvement activities to ensure PPD meets or exceeds client expectations for the implementation of quality management systems and processes. Ensures full compliance with CRG's procedures pertaining to quality investigations, quality audits and quality improvement initiatives. Provides mentorship and guidance to less experienced quality staff. Develops and maintains Client Product Specification Files Completes a Quality Review of Drug Product Manufacturing Records and prepares Release Documentation for the Qualified Person. Acts as the primary contact with customers on all aspects of GMP quality, the negotiation and management of customer Technical/Quality Agreements, the review of supporting documentation such as protocol, specifications, study summary etc. communicated directly with customer representatives to determine specific requirements and concerns, assume the lead in investigations and assure prompt responses to customer complaints and non-conformances, follows up to assure CAPA’s are implemented, tracked and closed in a timely manner plus assisting in hosting customer audits. Conduct audits or activities in area of expertise Provide project specific training to QA and/or manufacturing staff as applicable Acts as lead on client projects Maintain knowledge of regulations, SOP’s, QA departmental policies and procedures and demonstrate proficiency with audit procedures and proper documentation, in addition to knowledge in his/her area of expertise. Conduct audits or activities in area of expertise, e.g. review quality system and batch production records. Participates in client and regulatory inspections/audits and represent QA and following up on audit issues and corrective action. Participates in inter-departmental meeting and contribute to policy-making decisions. Education & Experience Requirements: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). *In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Required Knowledge, Skills, Abilities: Excellent oral and written communication skills Solid organizational and time-management skills Thorough knowledge and experience of the clinical trial process and GMP requirements Thorough knowledge and understanding of ICH GCP and other relevant regulations and guidelines Effective problem solving skills Strong attention to detail Ability to work independently as required Strong computer skills; ability to learn and become proficient with appropriate software Ability to multitask and prioritize competing demands/work load Demonstrated flexibility and adaptability Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs!