Quality Assurance Specialist (QAS) I

SOFIE Inc.; Houston (TX); On-site; USD 45,000 - 50,000; Full time

Job summary

SOFIE Inc. is seeking a Quality Assurance Specialist I to oversee the QA program and QMS at a SOFIE manufacturing site. The role ensures product quality and regulatory compliance across all operations.

You will collaborate with the Facility Manager and Operations team, write and approve SOPs, and participate in audits to maintain CGMP standards. A related degree and QA experience are required.

Qualifications

• Bachelor’s degree in science, quality, or related field.
• 1–2 years QA, Pharmacy, CGMP manufacturing experience preferred.
• Knowledge of USP, FDA, and cGMP regulations preferred.
• Ability to write, review, and revise SOPs.

Responsibilities

• Oversee QA program and QMS at a SOFIE manufacturing site.
• Apply QA processes to ensure product quality and regulatory compliance.
• Write, review, approve, and implement procedures and specs.
• Conduct audits and coordinate with inspectors and operations.

Skills

Strong interpersonal communication

Problem solving

MS Office proficiency

Communication with inspectors

Education

Bachelor’s Degree

Associate’s Degree

Tools

MS Office

Job 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 Range | $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