Quality Assurance Specialist I: QA & Compliance Lead

Description: Job Description | Quality Assurance Specialist (QAS) I Title | Quality Assurance Specialist I Department | Quality/Regulatory/EH&S Reports To | Regional Manager, Quality Assurance (or equivalent QA Manager) Compensation | $33-36/hr Overview The Quality Assurance Specialist I will be responsible for the oversight of the Quality Assurance program and the QualityManagement System at the site level. Essential Duties and Responsibilities

• Maintain oversight of the QA program and Quality Management System (QMS) at a single SOFIE manufacturingfacility 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 regulatorycompliance.
• Strong collaboration, including problem solving and continuous improvement efforts, and communication with theFacility 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 materialmeets its established specifications.
• Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finisheddosage 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. Mayinfrequently 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 facilitycertifications are maintained. Identify to management problems in personnel, equipment, and the facility that requirecorrection.
• Review documents associated with the site’s QA program for completeness, errors, and omissions. Reviewexecuted 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 preventiveactions and/or for continuous process improvement.
• Conduct continuous review of aseptic operations to ensure compliance to internal procedures (e.g., owning, 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 aretaken (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 (and211 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-specificprocedures relative to their job functions.
• Oversee the site-level change control process. Ensure that changes in the laboratory are accepted or rejected asappropriate, 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 up to two SOFIE products
• 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 externalvendors 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

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