Compliance Specialist III

Assistsinestablishingcurrentquality systems as they pertain to current industry regulatory and customer requirementsfor investigational new drugs biologics and/or medical devicesandmaintainingoperations in a state of control.Alsoassiststhe QA Director inmaintainingthe established systems.

• EstablishesStandard Operating Procedures (SOP)performsroutine maintenance of SOPs including periodic reviewstoassurealignment of systems with regulatory requirementsand global requirements. Provides training whentoassureretention.

• Audits departments for compliance to the quality systems generating audit reportsidentifyingtrends andestablishingperformance of the quality system

• Provides quality oversight ofvendorqualificationsi.e.questionnairesquality agreements vendor auditscheduleetc.

• MaintainsChangeControlDeviation Out of Specification Corrective and Preventative Action Complaintand investigation report system and follow-up actions.

• Assistsinmaintainingcompliance status of the facilityand audit readiness.

• Implements quality compliance and corrective action training.

• Trains new employeesand junior team memberson TFS procedures and cGMP regulations.

• Works independently on projectsas Quality Assurance Representativewith no supervision.

• Maintains current knowledge of ICH requirements toassurecomplianceofQuality systems.

• Responsible for ensuring that all APQRs are properly generated reviewed andsubmitted.

• Partnerwith site (Logistics and Quality Assurance) and network resources to provide oversight of supplier management and site-specific supplier qualityissues.

• Participate in cross-functional teams on process control improvement and optimization projects;participatein other continuous improvement projects to enhance clientsatisfaction.

• Other assignments and tasks as required.

REQUIREMENTS:

• Advanced Degree plus 2 years of experience or Bachelors Degree in Chemistry Biology or related scientific discipline plus 5 years of experience.

• Excellent project management and problem-solving abilities

• Strong written and verbal communication skills in English

• Ability to work independently and collaborate effectively in a matrix environment

• Proven track record of building relationships with suppliers and interdepartmental groups