Company Overview
OptioRx 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.
Job Summary
The Quality Control Supervisor provides day-to-day supervision and technical direction for Quality Control personnel supporting OptioRx 503A sterile and non-sterile compounding operations. This role bridges frontline QC execution and site Quality leadership by assigning work, monitoring documentation and testing workflows, supporting investigations, reinforcing procedures, escalating risks, and helping ensure QC activities are completed accurately, timely, and consistently with approved procedures and applicable quality requirements.
ESSENTIAL DUTIES
Quality Control Operations & Team Leadership
- Supervise the daily work of assigned QC personnel, including task assignment, prioritization, workflow monitoring, coaching, and escalation of workload or performance concerns to Quality leadership.
- Support onboarding, training, competency tracking, and day-to-day feedback for QC team members; provide input to performance evaluations as requested by the Quality Manager.
- Serve as the first-line technical resource for QC staff on documentation review, material controls, sample coordination, environmental monitoring records, visual inspection practices, and routine quality procedures.
- Monitor daily QC priorities and communicate status, delays, resource constraints, and quality risks to the Quality Manager or other appropriate site leadership.
Documentation, Batch Record Review, & Product Disposition.
- Oversee and support QC review of compounding records, batch records, labels, calculations, logs, Certificates of Analysis, laboratory reports, and related documentation for completeness, accuracy, traceability, and compliance with approved procedures.
- Identify documentation errors, missing information, discrepancies, or release-readiness concerns and ensure they are corrected, documented, or escalated according to procedure.
- Coordinate QC activities that support product disposition, including documentation readiness, testing status, inspection completion, material status, and quarantine controls, prior to final pharmacist disposition.
- Ensure products, materials, and components remain appropriately identified, segregated, and controlled while review, testing, investigation, or disposition activities are pending.
Incoming Materials, Components, & Supplier Quality
- Coordinate QC review, inspection, sampling, quarantine, acceptance, rejection, and status control of incoming materials, components, and packaging supplies.
- Verify required supplier and material documentation, including Certificates of Analysis, safety data sheets, lot information, expiration or retest dates, storage requirements, and traceability records.
- Ensure material concerns such as damage, labeling discrepancies, expiration, temperature excursion, suspect status, or nonconformance are documented and escalated to Quality leadership.
Visual Inspection, Laboratory Testing, & Data Review
- Coordinate visual inspection, sample submission, laboratory testing, and related documentation activities in accordance with approved procedures and assigned timelines.
- Review laboratory reports and supporting records for completeness, consistency with the requested test, and alignment with applicable specifications or acceptance criteria.
- Escalate atypical, invalid, out-of-specification, out-of-trend, conflicting, or delayed test results to Quality leadership and follow up with contract laboratories as directed.
Environmental Monitoring, Equipment, & Facility Quality
- Coordinate QC support for environmental and facility monitoring activities, including sample collection support, record review, and follow-up on missing or incomplete documentation.
- Review environmental monitoring and facility quality records for completeness, timeliness, excursions, adverse trends, and contamination-control concerns.
- Escalate environmental excursions, cleanroom certification findings, equipment or calibration concerns, and other facility-quality issues to Quality leadership for investigation or action.
Investigations, Deviations, OOS/OOT, CAPA, & Complaints
- Lead or support routine investigations involving documentation errors, deviations, nonconformances, OOS/OOT results, environmental excursions, material issues, complaints, or other quality events within assigned authority.
- Coordinate timely information gathering, containment support, product-impact documentation, root-cause input, and CAPA follow-up under the direction of Quality leadership.
- Escalate significant, repeat, high-risk, patient-safety, compliance, or data-integrity concerns to the Quality Manager or appropriate leadership.
- Provide QC input into change controls, document updates, validation activities, supplier issues, complaints, recall evaluations, and other quality-system processes as requested.
Metrics, Trending, & Continuous Improvement
- Compile and monitor assigned QC metrics, including batch review status, testing timelines, deviations, OOS/OOT results, environmental monitoring, material issues, visual inspection findings, complaints, CAPAs, and other quality indicators.
- Identify recurring issues, delays, adverse trends, or improvement opportunities and share observations with Quality leadership.
- Support management review, product quality review, and continuous improvement activities by preparing accurate data summaries and status updates, as assigned.
Training, Audit, & Inspectional Readiness
- Reinforce QC procedures, good documentation practices, material status control, deviation reporting, environmental monitoring documentation, and inspection conduct with QC and pharmacy personnel.
- Ensure assigned QC employees complete required training and competency activities before independently performing applicable work.
- Support audits, inspections, readiness activities, walkthroughs, document retrieval, audit responses, corrective action tracking, and remediation activities as directed by Quality leadership.
Cross-Functional Collaboration & Documentation
- Collaborate with site Quality, Corporate Quality, the Pharmacist-in-Charge, Quality Assurance, Operations, pharmacists, technicians, Training, Regulatory Affairs, vendors, and contract laboratories to support daily QC execution and issue resolution.
- Participate in operational, investigation, quality, and management review meetings by providing QC status updates, risks, timeline concerns, and follow-up actions.
- Maintain assigned QC records in approved systems and communicate documentation concerns, testing delays, quality risks, and required actions to appropriate stakeholders.
NON-ESSENTIAL DUTIES
- Support supplier quality activities, internal audits, mock inspections, accreditation or regulatory inspections, audit responses, corrective action tracking, and remediation activities, as assigned.
- Assist with product quality reporting, compliance walkthroughs, SOP or form updates, technical document review, and change-impact input under the direction of Quality leadership.
- Participate in special projects, quality improvement initiatives, training support, site support, vendor or laboratory visits, and other quality-related activities as business needs require.
CORE COMPETENCIES
- Quality Mindset – Maintains a patient-safety focused approach and reinforces quality expectations in daily QC work.
- Regulatory Awareness – Applies 503A compounding, USP <795>, USP <797>, USP <800>, documentation, data-integrity, and applicable pharmacy quality requirements.
- Frontline Leadership – Supervises daily work, coaches team members, sets priorities, and promotes accountability and follow-through.
- Technical Review – Reviews QC records, laboratory data, material documentation, and related quality records for completeness, accuracy, and compliance.
- Problem Solving – Recognizes issues, supports root-cause analysis, contributes to CAPA activities, and escalates risks appropriately.
- Communication – Communicates clearly with Quality leadership, pharmacy operations, vendors, laboratories, and cross-functional partners.
- Organization – Manages competing priorities, tracks follow-up items, supports timely completion of QC activities, and maintains inspection-ready records.
- Continuous Improvement – Identifies practical opportunities to improve QC workflows, documentation quality, compliance, and operational consistency.
QUALIFICATIONS
- Pharmacy Technician License required (Registered or Licensed).
- Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmacy, Pharmaceutical Sciences, Biotechnology, or a related scientific discipline preferred; equivalent directly relevant pharmacy, compounding, laboratory, pharmaceutical, or quality experience may be considered.
- Training or certification in USP <795>, <797>, <800>, aseptic technique, quality systems, root-cause analysis, internal auditing, or related areas preferred.
- Pharmacy technician certification, ASQ quality certification, or another relevant professional credential preferred but not required.
Experience
- Minimum two years of relevant Quality Control, Quality Assurance, compounding, pharmaceutical, laboratory, or regulated healthcare experience required.
- Minimum one year of supervisory, team-lead, training, or comparable leadership experience preferred.
- Experience reviewing quality records, laboratory results, environmental monitoring records, deviations, CAPAs, complaints, or change controls preferred.
PHYSICAL REQUIREMENTS
- Regularly required to sit, stand, walk, use computers and office or laboratory equipment, and communicate verbally and in writing; may occasionally bend, stoop, kneel, crouch, reach, and lift or move items up to 30 pounds.
- May require entry into sterile, non-sterile, warehouse, laboratory, cleanroom support, hazardous drug handling, or other controlled environments, subject to applicable gowning, PPE, safety, health, and site-specific requirements.
- Must be able to perform detailed visual review of records, labels, components, and compounded preparations and complete required hand hygiene, garbing, aseptic or sterile gowning, and environmental access qualifications when applicable.
Join us at OptioRx where your dedication to quality can make a meaningful impact on patient care! We value proactive leaders who thrive on continuous improvement and uphold the highest standards of safety and compliance in manufacturing environments.
Pay: $68,000.00 - $70,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
