Quality Assurance Specialist (Qas) I

Job Description | Quality Assurance Specialist (QAS) I Title | Quality Assurance Specialist I Department | Quality & Compliance Reports To | Regional Manager, Quality Assurance (or equivalent QA Manager) Overview The Quality Assurance Specialist I will be responsible for the oversight of the Quality Assurance program and the Quality Management System at the site level. Essential Duties and Responsibilities ▪ Maintain oversight of the QA program and Quality Management System (QMS) at a single SOFIE manufacturing facility producing products under both 21 CFR Part 212 and 211 (as needed) regulations. ▪ Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance. ▪ Strong collaboration, including problem solving and continuous improvement efforts, and communication with the Facility Manager and Operations team. ▪ Write, review, approve, and implement procedures, specifications, processes, and methods as required. ▪ Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications. ▪ Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications. ▪ Ensure that personnel are properly trained and qualified.

Ensure that the training is documented. ▪ Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site. ▪ Liaise with internal and external inspectors and representatives, particularly on QA-related topics. ▪ Oversee the metrology program at the site (i.e., equipment, personnel qualifications, validations, etc.). ▪ Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained.

Identify to management problems in personnel, equipment, and the facility that require correction. ▪ Review documents associated with the site’s QA program for completeness, errors, and omissions. Review executed CGMP records and product batch records to ensure compliance and product quality. ▪ Review trends (e.g., environmental monitoring, deviations, facility issues, etc.) to initiate corrective and preventive actions and/or for continuous process improvement. ▪ Conduct continuous review of aseptic operations to ensure compliance to internal procedures (e.g., gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations. ▪ Ensure any deviations from normal procedures are documented and justified. ▪ 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). ▪ Ensure compliance to all applicable standard operating procedures and regulations, including 21 CFR Part 212 (and 211 as needed) requirements. ▪ Ensure product complaints are managed in a manner consistent with Company SOPs and FDA regulations. ▪ Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions. ▪ Oversee the site-level change control process. Ensure that changes in the laboratory are accepted or rejected as appropriate, and ensure the changes are appropriately documented. ▪ Attend quality and operational meetings.

Interface with Corporate QA and Operations on quality related issues. Provide status updates as required management. ▪ Expected extensive knowledge of at least one SOFIE product. ▪ Other responsibilities as required. 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 general 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. ▪ Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required. Requirements for Quality Assurance Specialist (QAS) I ▪ 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, Pharmacy, and/or CGMP manufacturing experience