Compliance Specialist III

Work Schedule

Environmental Conditions

Job Description

Compliance Specialist III Process Validation Specialist

Provides quality oversight to ensure site compliance with GMP standards for small molecule drug substance manufacturing. Supports quality management systems including process validation Annual Product Reviews (APRs) process monitoring and data integrity while maintaining inspection readiness. Assist in establishing and maintaining quality systems aligned with industry regulatory and customer requirements supporting the Site Quality Head in ensuring operations remain in a state of control.

Key Responsibilities:

• Establishes Standard Operating Procedures (SOPs) performs routine maintenance of SOPs including periodic reviews to assure alignment of systems with regulatory requirements and global requirements. Provides training when required to assure retention.

• Audits departments for compliance with the quality systems generating audit reports identifying trends and establishing performance of the quality system
• Assist with supplier quality tasks (i.e. Approved Supplier List (ASL) vendor qualification and audits review).

• Maintains Change Control Deviation Out of Specification Corrective and Preventative Action Complaint and Quality Audit systems and their follow-up actions.

• Support facility compliance and inspection readiness including preparation for client and regulatory audits.
• Deliver training and coaching on TFS procedures process validation and cGMP regulations.

• Independently manage quality assurance projects as a Quality Assurance Representative ensuring compliance and effective execution of responsibilities.
• Stay current on ICH FDA and global regulatory requirements to maintain compliant quality systems.

• Collaborate with cross-functional teams including but not limited to Research & Development Logistics Procurement Manufacturing and Engineering on process control optimization and continuous improvement initiatives.

Education and/or Experience

• BS degree in Chemistry Biology or related scientific field preferred; will consider associate degree (AA/AS) with 5 years proven experience.
• 3 years of experience minimum required.

Language Skills

• Ability to read and comprehend sophisticated instructions correspondence and memos. Ability to write complex correspondence. Ability to optimally present information in one-on-one and small group situations to customers clients and other employees of the organization.

Interpersonal Skills

• Strong communication skills are required for client teamwork as well as technology transfer to other TFS sites. Skilled at tact in interpersonal communications.

Reasoning Ability

• Ability to apply intellectual understanding to carry out and issue detailed instructions. Ability to deal with complex situations with a wide variety of variables.

Digital Literacy

• To perform this job successfully an individual should have knowledge of Database software and Word Processing software.