Compliance Specialist
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!
Apply To This Job
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!
Apply To This Job