Compliance Specialist

Thermo Fisher Scientific•Morrisville, NC

21d•Remote

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. The Compliance Specialist executes quality and compliance processes across the organization and facilitates the tracking and reporting of quality and compliance activities.

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) is required.
Experience working in a GMP manufacturing environment, preferably in clinical trials or similar is required.
Experience working in the Quality Review of Manufacturing Records and prepares Release Documentation is required.
Experience working in cross-functional teams and in a high-pressured environment is required.
Experience working knowledge of GMP regulations is required.
Working knowledge and understanding of ICH GCP and other relevant regulations and guidelines is required.
Excellent oral and written communication skills
Solid organizational and time-management skills
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/workload
Demonstrated flexibility and adaptability
Must be legally authorized to work in the US without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.

Nice To Haves

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.

Responsibilities

Manages and leads all activities associated with project specific clients, regulatory, vendor, quality management, system, and/or internal audits and investigations.
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.
Conducts 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.