Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

A Day in the Life of a Compliance Specialist:

Man ages 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.

Per forms internal and external audit related activities as needed and escalates significant issues appropriately.

Contin ually ensures audit readiness of client files.

Contrib utes to quality process improvement activities to ensure PPD meets or exceeds client expectations for the implementation of quality management systems and processes.

Ensure s full compliance with CRG's procedures pertaining to quality investigations, quality audits and quality improvement initiatives.

Provi des mentorship and guidance to less experienced quality staff.

Dev elops and maintains Client Product Specification Files.

Com pletes a Quality Review of Drug Product Manufacturing Records and prepares Release Documentation for the Qualified Person.

Act s 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.

Con duct audits or activities in area of expertise.

Prov ide project specific training to QA and/or manufacturing staff as applicable.

Acts as lead on client projects.

Main tain 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.

Condu ct audits or activities in area of expertise, e.g. review quality system and batch production records.

Partici pates in client and regulatory inspections/audits and represent QA and following up on audit issues and corrective action.

Part icipates in inter-departmental meeting and contribute to policy-making decisions.

Qualification requirements:

Education requirements

Bachelo r's degree or equivalent and relevant formal academic / vocational qualification

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.

Experience requirements

Prev ious 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.

Knowledge, Skills, Abilities:

Excellent oral and written communication skills

Solid organizational and time-management skills

Eff ective 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

Demonst rated flexibility and adaptability

Location: Fully remote in the US Relocation assistance is NOT provided.

*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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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