Corporate Quality Assurance Specialist - Remote

PHARMALOGIC HOLDINGS

8d•Remote

About The Position

The Corporate Quality Assurance Specialist (CQAS) ensures stringent compliance with industry regulations and standard operating procedures. As a central figure in the Quality and Regulatory department, the CQAS supports site Quality Assurance Specialists. They bridge the gap between regulatory requirements, standard operating procedures, internal policies, and daily operations, championing both efficiency and excellence. As regulatory landscapes shift, the CQAS proactively positions the company at the forefront of compliance and best practices.

Requirements

Experience in Quality Assurance, Compliance, and Regulatory Affairs.
Experience in a PET manufacturing setting, adhering to 21 CFR 212 preferred.
Technical Writing skills.
Root Cause Analysis capabilities.
GC and HPLC. Experience.
Strong organizational, multitasking, and detail orientation.
Proficiency in communication, analysis, problem-solving, and teamwork mentality.
Flexibility for varying shifts and overnight on-call support.
Ability to travel up to 75%.

Responsibilities

Act as the central point of contact, providing Quality Assurance and Regulatory Affairs support and guidance to on-site QA.
Perform internal audits for US-based PET manufacturing locations. Analyze audit findings, ensure timely resolutions, and work to prevent recurrences.
Drive continuous improvements within the Quality Management System (QMS). Engage in consolidation and optimization of Standard Operating Procedures (SOPs), ensure teams are ready and equipped to implement new procedures, and foster collaboration to amplify the effectiveness and efficiency of PET operations.
Manage the initiation, review, and finalization of SOPs changes. Ensure they align with industry best practices and regulatory guidelines.
Lead corrective action planning and correspondence efforts post-audits, ensuring efficient and effective resolutions.
Collaborate with on-site QA teams to review and approve investigation reports, trending results, and CAPA to assure adequate corrective actions are implemented.
Assure the on-site QA teams are following the SOPs, documentation and filing practices, and internal policies and work with PET Operations to identify need for additional training or other personnel requirements.
Assist with Regulatory Affairs activities such as Annual Reporting, Field Alert Reports (FARs), FDA 483 responses, and other incidents that require FDA notification.
Ensure vendor qualifications are up-to-date and standardized throughout PET network, as appropriate.
Assist in QA review of sponsor-related documents with on-site QA, Technical Operations, and PET Operations teams for areas of concern; ensure site awareness of sponsor requirements.