Corporate Quality Assurance Specialist

Overview

PharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside. PharmaLogic offers you an exceptional opportunity to join our dynamic team

Job Overview: The Corporate Quality Assurance Specialist (CQAS) is integral to upholding the company's commitment to quality standards. This role ensures stringent compliance with industry regulations and standard operating procedures. As a central figure in Quality Assurance & Regulatory Affairs (QARA) department, the CQAS supports site Quality Assurance Specialists (QAS). 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.

1. Act as the central point of contact, providing Quality Assurance and Regulatory Affairs support and guidance to on-site QA teams. Offer guidance, expertise, and troubleshooting support as needed to ensure optimal operations.
2. Perform internal audits for US-based PET manufacturing locations. Analyze audit findings, ensure timely resolutions, and work to prevent recurrences. Collaborate with Operations and QARA Departments to maintain consistent quality standards.
3. 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.
4. Manage the initiation, review, and finalization of Standard Operating Procedures (SOPs) changes. Ensure they align with industry best practices and regulatory guidelines. Lead corrective action planning and correspondence efforts post-audits (external and internal), ensuring efficient and effective resolutions.
5. Collaborate with on-site QA teams to review and approve investigation reports (NCR/MCR/OOS/Deviations), trending results (including environmental monitoring data), and CAPA to assure adequate corrective actions are implemented.
6. 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.
7. Assist with Regulatory Affairs activities such as Annual Reporting, Field Alert Reports (FARs), FDA 483 responses, and other incidents that require FDA notification.
8. Ensure vendor qualifications are up-to-date and standardized throughout PET network, as appropriate.
9. 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.
10. On-call availability for overnight support.
11. Other related duties as assigned by the QARA Department.

Job Requirements / Skills / Education:

• 3 years' experience in Quality Assurance, Compliance, and Regulatory Affairs preferred
• 2 years' experience in a PET manufacturing setting adhering to 21 CFR 212 preferred
• Technical Writing skills
• Experience in Root Cause Analysis
• Experience with Gas Chromatography (GC) and HPLC is a plus
• Strong organizational, multitasking, and detail orientation
• Proficiency in communication, analysis, problem-solving, and teamwork mentality
• Flexibility for varying shifts
• Willingness to travel up to 75%

Manual dexterity for manipulating small items; regularly lift at least 50 pounds throughout each shift and to be able to lift 75 pounds on occasion. Able to handle standing, walking and sitting for 4+ hours with limited rest intervals; good eye-hand coordination; fair eyesight (with or without correction lenses); normal hearing in at least one ear (hearing range of 20 Hz to 20 kHz); ability to analyze situations, set priorities and meet deadlines while maintaining attention to detail in a fast-paced and dynamic environment; effective organizational skills; a commitment to continuous learning; an ability to work well both independently and as part of a team.

PharmaLogic is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.

• 401(k) retirement benefit program
• Medical
• Dental care
• Disability insurance
• Employee assistance program
• Extended health care
• Life insurance
• Paid time off
• Vision care