Quality Assurance Specialist (Qas) I, Capa/Cc

Job Description | Quality Assurance Specialist (QAS) I, CAPA/CC
Title | Quality Assurance Specialist (QAS) I, CAPA/CC
Location | Hybrid, based out of any SOFIE facility
Department | Quality & Compliance
Reports To | QA Manager, CAPA/CC
Overview
SOFIE is committed to all aspects of Quality and Compliance in the production of the Radiopharmaceutical products they manufacture. This role supports SOFIE's Corrective/Preventive (CAPA) and Change Control (CC) quality systems under supervision of the QA Manager, CAPA/CC. SOFIE aseptically manufactures therapeutic and diagnostic radiopharmaceuticals across the US. The successful candidate will provide Quality Assurance support to the network with specific emphasis on change control and corrective and preventive actions. This person will play an active and integral part of the Quality team, supporting compliance, improvement, and implementation with all products at all SOFIE facilities.
Essential Duties and Responsibilities

• Assist with Quality Assurance initiatives and provide support with Quality Management System (QMS) compliance at is relates to SOFIE 21 CFR Part 212 network facilities.
• Review Change Control, Deviation, OOS investigation, and CAPA when necessary. Closely track and follow-up on these activities for timely closure. Ensure that scientifically sound investigations are conducted, and root causes are identified. Initiate and implement CAPA plans. Evaluate effectiveness of the CAPA plans through reporting and trending.
• Provide backup support - remote and in-person - to network facilities on CAPA/CC and other quality documentation.
• Hosts CAPA and Change Control review boards and presents CAPA and Change Control training topics to applicable staff, as necessary.
• Apply Quality Assurance processes and procedures at the corporate level to ensure product quality and regulatory compliance.
• Ensure that the network cGMP documents are properly organized, controlled, and securely archived.
• Write, review, and implement procedures, specifications, processes, and methods as required.
• Review executed CGMP records and product batch records to ensure compliance and product quality, when needed.
• Review trends (e.g., environmental monitoring, deviations, facility issues, etc.) to initiate corrective and preventive actions and/or for continuous process improvement.
• Ensure an investigation is performed and documented when required, and corrective and preventative actions are taken (i.e., follow and maintain corporate CAPA, deviation, and OOS protocols).
• Conduct periodic audits of network sites to monitor compliance with established procedures and practices.
• Liaise with internal and external inspectors and representatives, particularly on QA-related topics, including supporting partner and FDA inspections.
• Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to job function.
• Maintain knowledge of current regulations and quality policies. Attend quality related meetings and conference calls. Interface with corporate QA on quality related issues.
• Provide quality status updates as required by corporate QA.
• Other responsibilities as assigned by QA Manager, CAPA/CC.
• May be assigned other specialty area(s) as business need arises. Assignments may include Supplier Management, Electronic Systems, etc.
• Domestic travel up to 25% travel.

Qualifications
• Bachelor's Degree (Scientific / Medical / Quality), at minimum, preferred.
• Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred.
• Quality, Pharmacy, or CGMP manufacturing experience preferred.
• Knowledge of USP, FDA, and cGMP regulations preferred.
• Knowledge of how and ability to write, review, and revise SOPs required.
• Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.
• Ability to write reports, business correspondence, and procedure manuals required.
• Ability to effectively present information, deliver training, and respond to questions from groups of managers, clients, customers, and the public required.
• Ability to define problems, collect data, establish facts, and draw valid conclusions required.
• Ability to solve problems and handle issues required.
• Proficient in MS Office applications required.
• Excellent analytical, prioritization, multi-tasking, communication, strong leadership skills, and the ability to work independently with limited supervision required.
• Ability to effectively communicate (written and verbal) with site personnel, corporate QA, customers, partners, and regulatory agencies required.
• Ability to project manage and have excellent organization and prioritization skills.
Requirements for Quality Assurance Specialist I, CAPA/CC
• Associate's or Bachelor's Degree, at minimum
• Relevant certifications and/or experience may be substituted in lieu of this requirement.
• 1-2 years of QA and/or CGMP manufacturing experience