Quality Assurance Specialist

Company Description Xseer Pharmaceuticals is an FDA-registered 503B outsourcing facility and cGMP-compliant Contract Development and Manufacturing Organization (CDMO) headquartered in Los Angeles, California. The company focuses on bridging the gap between clinical demand and reliable pharmaceutical supply, delivering consistent quality from formulation through finished product. Compliance and regulatory clarity underpin every aspect of Xseer’s operations. Team members work with state-of-the-art ISO-class cleanrooms, advanced aseptic robotic filling, and automated visual inspection systems. Xseer is dedicated to advancing patient care through technical excellence, operational reliability, and a strong quality culture. Role Description The Quality Assurance Specialist is a full-time, on-site role based in Los Angeles, CA. This position is responsible for performing routine quality assurance activities, including batch record review, documentation control, deviation and CAPA management, and change control. The specialist will conduct internal audits, support regulatory and customer inspections, and verify adherence to cGMP and internal quality standards. Daily tasks include collaborating with production, quality control, and engineering teams to resolve quality issues, reviewing and approving SOPs, and monitoring key quality metrics. The role also involves participating in risk assessments, training staff on quality procedures, and contributing to continuous improvement initiatives that enhance product and process reliability. Qualifications Candidates should possess skills in Quality Assurance and Quality Management, including experience implementing and maintaining quality systems in a regulated environment. Candidates should possess skills in Quality Control and Quality Auditing, with the ability to conduct inspections, review records, and identify nonconformances. Candidates should possess knowledge of Good Manufacturing Practice (GMP), particularly FDA and cGMP requirements applicable to pharmaceutical manufacturing. Relevant experience in pharmaceutical, biotechnology, or sterile manufacturing operations is strongly preferred. Strong attention to detail, analytical problem-solving abilities, and proficiency in technical documentation and report writing. Effective communication and collaboration skills, with the ability to work cross-functionally and support a culture of quality and continuous improvement. Bachelor’s degree in a scientific or technical discipline (such as Chemistry, Pharmacy, Biology, Engineering, or related field) or equivalent relevant experience. #J-18808-Ljbffr