Quality Control Technician - Sterile Pharmacy Technician - CPhT - Required

Position Summary

The Quality Control Technician supports quality oversight for OptioRx'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.

Essential Duties

• 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 readiness, audit preparedness, and ongoing compliance with pharmacy quality requirements.
• Maintain accurate, complete, and inspection-ready quality records in accordance with applicable retention, documentation, and data integrity expectations.

Non-Essential Duties

• Participate in and/or lead meetings to provide input on timelines, potential compliance concerns, quality priorities, and related QC activities.
• Support special projects, inspections, audits, training initiatives, and quality improvement activities as assigned.
• Travel to other OptioRx locations for audits, training, inspections, or quality support activities as needed.

Qualifications

• Bachelor's degree in a science-related field, such as Chemistry, Biology, Pharmacy, or a related discipline, preferred.
• Certified Pharmacy Technician Required.
• Minimum one year of pharmacy technician required. 1+ year combined quality experience in 503A drug product compounding, process development, commercial manufacturing, analytical development, quality control, biotechnology, or pharmaceutical operations preferred.
• Working knowledge of Quality Assurance systems, quality risk assessment principles, investigations, CAPAs, deviations, complaints, change control, and document control processes required.
• Ability to read, understand, evaluate, and appropriately revise controlled documents, including batch records, quality agreements, SOPs, and related quality records.
• Strong technical writing, documentation, troubleshooting, analytical, and problem-solving skills required.
• Effective organizational, planning, prioritization, interpersonal, and communication skills required, including the ability to communicate with staff at all levels, including executives.
• Ability to visually inspect and identify small particulates, fibers, and other defects in glass vials.
• Ability to work independently, remain composed under pressure, meet tight deadlines, and adapt to frequent changes, delays, or unexpected events in a rapidly changing environment.
• Ability to collaborate effectively, support team goals, and provide guidance or coaching to junior employees as appropriate.
• Ability to develop and present quality-related training materials and participate in quality-related meetings and discussions.
• Ability to aseptically gown and/or sterile gown as needed and work within cleanroom environments.
• Familiarity with USP 795, USP 797, USP 800, FDA guidance, State Board of Pharmacy requirements, accreditation standards, and data integrity expectations preferred.
• Ability to work on site and travel up to approximately 5% to other OptioRx locations for audits, training, or inspections as needed.
• Ability to wear required gowning and PPE for cleanroom entry and perform frequent walking and standing during observations.
• Ability to sit for extended periods, occasionally lift up to 25 pounds, and inspect vials using a light box for extended periods.

Core Competencies

• Quality and compliance mindset
• Attention to detail and documentation accuracy
• Analytical thinking and sound judgment
• Problem solving and root cause analysis
• Technical writing and professional communication
• Collaboration and cross-functional partnership
• Leadership, coaching, and quality culture development