Quality Control Technician - Sterile Pharmacy Technician - CPhT

Optio Rx/SBH Medical is a dynamic premier national compounding pharmacy providing best in class patient care. We serve 50 states and are committed to fostering a team environment rooted in trust, innovation, efficiency, accountability, integrity, and energy.

The Quality Control Technician supports quality oversight for Optio Rx’s 503A compounding pharmacy operations by helping ensure compliance with applicable quality standards, regulatory requirements, internal policies, and established procedures. This position is responsible for reviewing batch records and quality documentation, supporting product disposition, assisting with deviation and complaint investigations, monitoring quality systems, and trending quality data. The role requires a detail-oriented professional with strong technical writing skills, sound compliance judgment, and quality assurance experience in a pharmaceutical, biotechnology, or compounding pharmacy environment.

• Review completed compounding records, batch records, Certificates of Conformance, Certificates of Analysis, raw data, and related documentation to support timely product disposition, batch release, record retention, testing, validation, and distribution activities.
• Provide Quality Assurance oversight to support compliance with applicable quality standards, internal SOPs, regulatory requirements, and product safety and quality expectations.
• Manage and support quality system documentation and processes, including deviations, Out of Specification results, product complaints, CAPAs, document control, change control, SOPs, Master Batch Records, technical documents, and related approvals.
• Lead, support, write, and review investigations related to deviations, OOS results, QC testing, complaints, and other quality events; identify root causes, recommend corrective and preventive actions, and support implementation of CAPAs and change controls.
• Collect, maintain, analyze, and report Continued Process Verification data, quality metrics, product and process trends, and quality system performance information for management reviews and operational KPIs.
• Assist in implementing, maintaining, and applying quality risk management frameworks and risk assessment principles to support compliant and effective quality decisions.
• Collaborate with the General Manager, Staff Pharmacists, Director of Quality, and cross-functional team members to resolve minor and major deviations, strengthen quality systems, and maintain alignment with internal procedures and regulatory expectations.
• Support product complaint-handling activities and assist with preparation of the Annual Product Quality Report.
• Conduct or support audits of supplier quality systems, APIs, excipients, packaging, and related manufacturing or compounding processes to evaluate compliance with applicable standards and regulations, including USP 795, USP 797, USP 800, FDA requirements, State Boards of Pharmacy, NABP VPP, and ACHC expectations.
• Oversee or support equipment and software qualification, calibration, and validation activities to maintain quality system readiness and compliance.
• Conduct and support employee training on quality processes, documentation practices, compliance expectations, and quality system requirements as needed.
• Support a strong quality culture through collaboration, coaching as appropriate, and consistent adherence to company values and quality expectations.
• Monitor environmental, cleaning, maintenance, and personnel training records to support cleanroom…