Quality Assurance Specialist : 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 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., 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 (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 up to two SOFIE products

▪ Other responsibilities as required.

Qualifications…