PharmaLogic · 11 hours ago
Corporate Quality Assurance Specialist - Remote
United States
Full-time
Remote
Mid Level
$80K/yr - $95K/yr
3+ years expPharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization, seeking a Corporate Quality Assurance Specialist. This role is vital for ensuring compliance with industry regulations and standard operating procedures, while supporting Quality Assurance and Regulatory Affairs efforts across the organization.
Pharmaceuticals
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
Periodic on-call availability for overnight support
Other related duties as assigned by QARA Department
Qualification
Required
3 years' experience in Quality Assurance, Compliance, and Regulatory Affairs
2 years' experience in a PET manufacturing setting adhering to 21 CFR 212
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%
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
Preferred
Experience with Gas Chromatography (GC) and H.P.L.C
Benefits
401(k) retirement benefit program
Medical
Dental care
Disability insurance
Employee assistance program
Extended health care
Life insurance
Paid time off
Vision care
Company
PharmaLogic
PharmaLogic is a leading global contract development and manufacturing organization (CDMO) specialized in diagnostic and therapeutic radiopharmaceuticals.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Keith Kennedy
Chief Financial Officer
Deborah Vanerka
Chief Revenue Officer (CRO)
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