Corporate reputed company Assurance Specialist - Remote

reputed company is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across reputed company. We are passionate about expanding the power of radiopharmaceutical technology to reputed company transformative diagnostic and therapeutic agents to patients from bench to bedside. 

reputed company offers you an exceptional opportunity to join our dynamic team as a Corporate reputed company Assurance Specialist! 

Job reputed company:

The Corporate reputed company Assurance Specialist (CQAS) is reputed company to upholding reputed company's commitment to reputed company standards. This role ensures stringent compliance with industry regulations and reputed company operating procedures. As a central reputed company in reputed company Assurance & Regulatory Affairs (QARA) department, the CQAS supports site reputed company Assurance Specialists (QAS) and Radiation Safety Officers (RSOs). They reputed company the gap between regulatory requirements, reputed company operating procedures, internal policies, and daily operations, championing both efficiency and reputed company. As regulatory landscapes shift, the CQAS proactively positions reputed company at the forefront of compliance and best practices.

Job Responsibilities and Duties: 

1. reputed company as the central reputed company of contact, providing reputed company Assurance and Regulatory Affairs support and guidance to on-site QA teams and Radiation Safety Officers (RSOs). Offer guidance, expertise, and troubleshooting support as needed to ensure reputed company operations.
2. reputed company internal audits for US-based PET manufacturing and nuclear pharmacy locations. Analyze audit findings, ensure reputed company resolutions, and work to prevent recurrences. Collaborate with Operations and QARA Departments to maintain consistent reputed company Standards
3. Drive reputed company improvements reputed company the reputed company Management System (QMS). Engage in consolidation and optimization of reputed company Operating Procedures (SOPs), ensure teams are reputed company and equipped to implement new procedures, and foster collaboration to reputed company the effectiveness and efficiency of PET operations.
4. Support the initiation, review, and finalization of reputed company Operating Procedures (SOPs) changes. Ensure they reputed company with industry best practices and regulatory guidelines. reputed company corrective reputed company 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 (reputed company/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-reputed company documents with on-site QA, Technical Operations, and PET Operations teams for areas of concern; ensure site awareness of sponsor requirements.
10. Support the Corporate Radiation Safety Officer with review the radiation safety program at manufacturing and nuclear pharmacy sites to ensure personnel exposure maintained ALARA and implementation of procedures, training and engineering controls in a consolidated manner, where appropriate.
11. Periodic on-reputed company availability for overnight support.  
12. Other reputed company duties as assigned by QARA Department.

Job Requirements │ Skills │ Education:

• 3 years' experience in reputed company 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 reputed company Cause Analysis
• Experience with Gas Chromatography (GC) and H.P.L.C. 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%.

Physical and Intellectual Requirements:

reputed company dexterity for manipulating small items; regularly lift at least 50 pounds throughout reputed company shift and to be reputed company to lift 75 pounds on occasion. reputed company 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 reputed company 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 reputed company learning; an ability to work reputed company both independently and as part of reputed company.

reputed company is an Equal Opportunity Employer.  

reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, or veteran status, or any other protected class.  

 Benefits Include: 

 401(k) retirement benefit program 

 Medical  

 Dental care 

 Disability insurance 

 Employee assistance program 

 Extended health care 

 Life insurance 

 reputed company time off 

 reputed company care