Overview

The Quality Assurance Specialist I, Corporate (Floater) will be responsible for support of the Quality Management System across the SOFIE Network.

Essential Duties and Responsibilities

Assist with quality assurance initiatives and provide support with Quality Management System (QMS) compliance at SOFIE 21 CFR Part 212 network facilities.

Provide backup support, remote and in-person, to network facilities on exception Management and CAPA/CC and other quality documentation.

Provide back-up support on Document Control functions such as distributing, tracking, and maintaining quality documents and processing procedures via electronic signatures (estimated 40% of the time).

Participate in continuous improvement initiatives including, but not limited to, supporting the configuration of new electronic platforms, designing and presenting training, and executing CAPA/CC initiatives.

Serve in a backup capacity for site Quality Assurance Specialists (up to ~75%). In this capacity:

o Provide support of the QA program and Quality Management System (QMS) at designeted SOFIE manufacturing facility producing products under both 21 CFR Part 212 and 211 (as needed) regulations.

o Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance.

o Strong collaboration, including problem solving and continuous improvement efforts, and communication with the Facility Manager and Operations team.

o Write, review, approve, and implement procedures, specifications, processes, and methods as required.

o Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.

o 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.

o Ensure that personnel are properly trained and qualified. Ensure that the training is documented.

o Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site.

o Liaise with internal and external inspectors and representatives, particularly on QA-related topics.

o Oversee the metrology program at the sites (i.e., equipment, personnel qualifications, validations, etc.).

o 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.

o 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.

o Review trends (e.g., environmental monitoring, deviations, facility issues, etc.) to initiate corrective and preventive actions and/or for continuous process improvement.

o 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.

o Ensure any deviations from normal procedures are documented and justified.

o 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).

o Ensure compliance to all applicable standard operating procedures and regulations, including 21 CFR Part 212 (and 211 as needed) requirements.

o Ensure product complaints are managed in a manner consistent with Company SOPs and FDA regulations.

o Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.

o 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.

This position requires up to ~75% travel (continental U.S.)

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.

The description provided above is not intended to be an exhaustive list of all job duties, responsibilities, and requirements. Duties, responsibilities, and requirements may change over time and according to business need.