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PharmaLogic Holdings Corp. ยท 3 days ago
Corporate Quality Assurance Specialist
United States
Full-time
Remote
Mid Level
3+ years exp
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Responsibilities
Act as the central point of contact, providing Quality 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 optimal operations.
Perform internal audits for US-based PET manufacturing and nuclear pharmacy locations. Analyze audit findings, ensure timely resolutions, and work to prevent recurrences. Collaborate with Operations and QARA Departments to maintain consistent quality standards.
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.
Support 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.
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.
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.
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.
Other related duties as assigned by QARA Department.
Qualification
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Required
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
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%
Preferred
Experience with Gas Chromatography (GC) and H.P.L.C. is a plus
Benefits
401(k) retirement benefit program
Medical
Dental care
Disability insurance
Employee assistance program
Life insurance
On-site parking
Paid time off
Vision care
Company
PharmaLogic Holdings Corp.
PharmaLogic is a world-class contract development and manufacturing organization specializing in novel diagnostic imaging and therapeutic radiopharmaceuticals for the treatment of cancers and other malignancies.
501-1,000 employees
Funding
Current Stage
Late StageLeadership Team
Keith Kennedy
Chief Financial Officer
Deborah Vanerka
Chief Revenue Officer (CRO)
Company data provided by crunchbase
