Quality Control Technician

Vios Compounding Pharmacy, in Livonia, Michigan, is hiring a Quality Control Technician. Vios is a 503A Compounding Pharmacy that prepares patient specific drugs. Vios prepares non-sterile (topical creams, capsules, troches, etc.) and sterile (injectables) compounded drugs. Quality is a vital component of drug preparation, and as such, the Vios quality team is looking to expand.

Summary:

The Quality Control (QC) Technician is a key member of the Quality Assurance team, responsible for ensuring that all compounded sterile and non-sterile preparations comply with established internal Standard Operating Procedures (SOPs), state and federal regulations, including USP General Chapters 795, 797 & 800 and meet the highest standards of safety, identity, strength,quality, and purity. This role is highly focused on execution, documentation review, environmentalmonitoring, and supporting the pharmacy's continuous quality improvement (CQI) program.

Responsibilities:

1. Quality Control Testing and Release Checks

 Final Product QC: Conduct and document physical quality checks on final compounded drug products (CSPs and non-sterile preparations) for correct labeling, physical appearance (e.g., color, clarity, absence of particulates), and container integrity prior to release.

 Filter Integrity Testing: Perform and document integrity testing (bubble point testing) on sterile filtration devices used in compounding to ensure the successful removal of microorganisms and particulates.

 Aseptic Technique Assessment: Assist in the direct observation and periodic visual assessment of compounding personnel's aseptic technique, garbing procedures, and hand hygiene during media fills and routine operations.

1. Environmental Monitoring and Facility Oversight

 Monitoring Execution: Execute the comprehensive environmental monitoring program, including collecting viable air and surface samples within the ISO Class 5 Primary Engineering Controls (PECs), ISO Class 7 Buffer Rooms, and ISO Class 8 Ante-Rooms.

 Basic Microbiology: Perform rudimentary laboratory tasks such as plate incubation, documenting growth, and colony counting (CFU determination) of viable samples.

 Inspection: Conduct routine and documented inspections of the compounding environment to ensure adherence to cleanliness standards, proper sanitization logs, and compliance with the facility design requirements of USP 797 and USP 800 (Hazardous Drugs).

1. Documentation Review and Compliance Auditing

 Documentation Review: Review compounding records, weighing and measuring logs, cleaning logs, and batch records for accuracy, completeness, and adherence to established policies and procedures. Ensure proper calculations and double-check signatures are present.

 Data Integrity: Verify that all data recorded, including equipment calibration andenvironmental readings, is accurate, legible, and attributable to the correct process step.

 Auditing: Participate in and support the execution of internal audits to proactively identify non-conformances and potential gaps in the Quality Management System (QMS).

1. Quality Management System Support (CAPA, Investigation, SOP)

 Investigations: Participate in the investigation of product quality complaints, out-of-specification (OOS) results, and environmental monitoring excursions, assisting in the Root Cause Analysis (RCA) process.

 CAPA Activities: Assist in the development, documentation, and tracking of Corrective andPreventive Actions (CAPA) to address identified deficiencies, deviations, and audit findings.

 Documentation: Assist Quality Assurance personnel in the drafting, review, and revision of Standard Operating Procedures (SOP), batch records, and quality control forms. Required Qualifications and Competencies

 Education: Associate's Degree or higher in a relevant science field (e.g., Chemistry, Biology, Pharmaceutical) is preferred.

 Experience: Previous experience (minimum 1-3 years) in a highly regulated laboratory, pharmaceutical, or healthcare setting, preferably within a compounding or manufacturing environment.

 Quality Systems: Strong working knowledge of the principles of an ISO 9000-based Quality Management System (QMS) or similar quality frameworks.

 Technical Skills: Demonstrated strong understanding of aseptic technique and basic cleanroom operations. Proficiency in rudimentary microbiology colony counting and documentation.

 Detail Orientation: Exceptional attention to detail, strong analytical and problem-solving skills, and a commitment to data integrity and accurate documentation.

 Regulatory Knowledge (Preferred): Familiarity with FDA regulations (e.g., USP, 21 CFR 211 and 21 CFR 210, cGMP concepts) as they relate to pharmacy compounding is desirable.

Physical Demands:

 The Quality Control Technician must be able to lift and move up to 50 pounds.

 The Quality Control Technician must be able to stand for long periods of time.

Pay: $ $25.00 per hour

Expected hours: 40.0 per week

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person