Quality Assurance Specialist

About OSRX Inc.:

OSRX Inc. is a registered 503B Outsourcing Facility, compounding ophthalmic solutions. Our state-of-the-art compounding pharmacy combines multiple medications into a single bottle to simplify dosing and streamline care. We do this because we believe in putting patients ahead of profits. In engineering simple solutions to solve complex problems. In disrupting the status quo. We have A New View of Medicine®.

Job Description:

The Quality Assurance Specialist is responsible for supporting the Quality Management System (QMS) in compliance with current Good Manufacturing Practices (cGMP) and FDA 21 CFR Part 210, 211, and 503B requirements. This position ensures that all compounding, labeling, testing, and distribution activities meet regulatory standards, internal procedures, and customer expectations.

Job Responsibilities:

• Review and approve production batch records, and logs for accuracy, completeness, and compliance prior to product release.
• Perform line clearance in manufacturing areas.
• Participate in deviation and nonconformance investigations.
• Review and maintain controlled documents, including Standard Operating Procedures (SOPs), forms, logs, and specifications.
• Review and approve vendor qualifications, certificates of analysis (COAs), and raw material release documentation.
• Perform environmental and personnel monitoring sampling.
• Monitor environmental and personnel monitoring data to ensure state of control within the cleanroom.
• Assist with training activities to ensure staff are qualified and maintain competency for cGMP operations.
• Support validation activities (equipment, process, analytical, and cleaning) as part of ongoing quality oversight.
• Maintain quality metrics, trending, and reports as part of the continuous improvement process.

Education and Experience

• Experience in Quality Assurance or Quality Control
• Experience with cGMP or USP preferred
• Familiarity with sterile compounding operations and aseptic processing principles

Skills and Competencies

• Strong attention to detail, organization, and documentation accuracy.
• Ability to interpret and apply cGMP regulations and quality standards.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite
• Strong problem-solving skills and ability to work both independently and collaboratively.

Working Conditions

• Typically 8 Hour shifts Monday-Friday
• Work performed in both office and classified cleanroom environments.
• May require gowning and adherence to aseptic gowning qualifications.
• Occasional lifting (up to 25 lbs), standing, or walking for extended periods in controlled environments.
• Must pass a background check and toxicology screening prior to hire.
• Benefits offered after qualified employment term.

Job Type: Full-time

Pay: $18.00 - $23.00 per hour

Expected hours: No less than 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance