Quality Control Technician - Sterile Pharmacy Technician (CPhT Required)

OptioRx; Glendale (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

OptioRx is seeking a Quality Control Technician to oversee quality for 503A compounding pharmacy operations. The role reviews batch records, supports product disposition, and participates in deviation investigations to uphold regulatory and internal standards.

The position requires strong technical writing, attention to detail, and collaboration with the General Manager and Director of Quality to maintain compliant processes within a fast-paced environment.

Qualifications

• Bachelor’s degree in a science-related field preferred.
• Strong technical writing, documentation, troubleshooting, analytical and problem-solving skills.
• Effective organizational, planning, prioritization, interpersonal and communication skills.
• Ability to read, understand, evaluate, and revise controlled documents.

Responsibilities

• Review completed compounding records, batch records, Certificates of Conformance, CoA and raw data to support product disposition and batch release.
• Provide Quality Assurance oversight to ensure compliance with quality standards and regulatory requirements.
• Manage quality system documentation including deviations, OOS results, CAPAs, document control and change control.
• Lead investigations related to deviations, OOS, complaints and other quality events; identify root causes and support CAPA implementation.
• Analyze and report quality data and metrics for management reviews and operational KPIs.
• Assist with risk management frameworks and ensure compliant quality decision making.
• Collaborate with cross-functional teams to resolve deviations and strengthen quality systems.
• Support product complaint handling and preparation of the Annual Product Quality Report.
• Conduct or support audits of supplier quality systems and manufacturing processes to verify compliance with standards.
• Oversee equipment and software qualification, calibration and validation activities.

Education

Bachelor’s degree in a science-related field

Job description

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. 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.

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.
• 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: Demonstrates consistent commitment to patient safety, regulatory compliance, quality standards, and adherence to established procedures.
• Attention to detail and documentation accuracy: Produces complete, accurate, and inspection-ready records while identifying discrepancies, errors, or gaps that may impact quality outcomes.
• Analytical thinking and sound judgment: Evaluates information objectively, applies quality principles, and uses sound judgment to support compliant and effective decisions.
• Problem solving and root cause analysis: Identifies issues, investigates contributing factors, determines likely root causes, and supports practical corrective and preventive actions.
• Technical writing and professional communication: Communicates clearly, accurately, and professionally through written documentation, investigation summaries, training materials, and cross-functional interactions.
• Collaboration and cross-functional partnership: Builds productive working relationships across pharmacy, quality, compliance, and operations teams to resolve issues and support shared goals.
• Leadership, coaching, and quality culture development: Models quality-focused behaviors, supports team learning, provides guidance when appropriate, and reinforces accountability for compliant practices.

This job description is not intended to be all-inclusive. The employee may be required to perform other related duties as assigned to meet ongoing business needs.

Employee Acknowledgment

I have reviewed and understand the duties, responsibilities, and expectations of this position. I acknowledge that this job description is not an exhaustive list and that I may be asked to perform other duties as assigned.