Quality Assurance Specialist I at SOFIE

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