Quality Assurance Specialist (QAS) I

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.
• Collaborate, problem‑solve, and drive continuous improvement with the Facility Manager and Operations team.
• Write, review, approve, and implement procedures, specifications, processes, and methods as required.
• Oversee examination and evaluation of each lot of incoming material before use to ensure it meets established specifications.
• Ensure components, containers, closures, in‑process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to meet current specifications.
• Ensure personnel are properly trained, qualified, and that training is documented.
• Conduct periodic site audits to monitor compliance with established procedures and practices; may infrequently audit another site.
• Liaise with internal and external inspectors and representatives on QA‑related topics.
• Oversee the metrology program at the site (equipment, personnel qualifications, validations, etc.).
• Ensure manufacturing and analytical equipment is appropriately maintained and calibrated; maintain applicable facility certifications; identify 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) to initiate corrective and preventive actions and/or continuous process improvement.
• Conduct continuous review of aseptic operations to ensure compliance with internal procedures (gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations.
• Ensure any deviations from normal procedures are documented and justified.
• Ensure investigations are performed and documented when required, and that corrective and preventative actions are taken in accordance with corporate CAPA, deviation, and OOS protocols.
• Ensure compliance with all applicable standard operating procedures and regulations, including 21 CFR Part 212 (and 211 as needed) requirements.
• Manage product complaints in a manner consistent with Company SOPs and FDA regulations.
• Open change controls and initiate, maintain, and review SOFIE network and site‑specific procedures relative to job functions.
• Oversee the site‑level change control process; ensure laboratory changes are accepted or rejected as appropriate and documented.
• Attend quality and operational meetings; interface with Corporate QA and Operations on quality‑related issues and provide status updates to management.
• Maintain extensive knowledge of at least one SOFIE product.

Qualifications

• Other responsibilities as required.
• Bachelor’s Degree (Scientific / Medical / Quality) preferred; Associate’s degree acceptable if supplemented by relevant certifications or experience.
• Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred.

Preferred Qualifications

• Quality, Pharmacy, or cGMP manufacturing experience.
• Knowledge of USP, FDA, and cGMP regulations.
• Ability to write, review, and revise SOPs.
• Ability to read, analyze, and interpret governmental regulations, professional journals, and technical procedures.
• Ability to read and interpret safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information, deliver training, and respond to questions from managers, clients, customers, and the public.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Strong problem‑solving skills.
• Proficiency in MS Office applications.
• Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal/external vendors.

Requirements

• Associate’s or Bachelor’s Degree, at minimum; relevant certifications and/or experience may be substituted.
• 1–2 years of QA, Pharmacy, and/or cGMP manufacturing experience.