Quality Technician 503B

Job Description

Job Description

Role Summary

The Quality Technician ensures that all compounded products are manufactured in accordance with current Good Manufacturing Practices (GMP) and also meet all internal specifications. This position is responsible for performing a number of manual and automated quality assurance checks on in-process products and finished goods. This position requires strong organizational skills and the ability to prioritize work and respond to customer demands in a timely fashion are critical requirements of this position. This position is responsible for working collaboratively with other personnel in the Quality Department to ensure the highest quality product is delivered to the consumer.

Job Activities and Responsibilities:

• Collect and send samples of compounded sterile preparations (CSPs) for sterility, potency, and endotoxin testing.
• Conduct environmental monitoring (e.g., air and surface sampling) in cleanrooms to ensure compliance with regulatory standards.
• Perform visual inspection of finished drug products.
• Maintain incubation schedules of environmental monitoring sample plates and document results in associated reports and batch records.
• Maintain accurate and thorough records of all testing and inspections.
• Ensure all documentation complies with FDA 503B regulations, USP standards, and internal SOPs.
• Review batch records and verify that all procedures were followed correctly.
• Assist in internal and external audits to ensure compliance with FDA regulations, USP <797> , USP <795> , and other applicable guidelines.
• Work closely with the Quality Assurance (QA) team to implement corrective and preventive actions (CAPAs) when non-conformities are identified.
• Maintain effective communication and partnership with Operations Management department.
• Participate in root cause analysis to find the sources of defects or quality problems.
• Ensure that all QC laboratory equipment is properly calibrated and maintained according to the manufacturer’s specifications.
• Review of draft and executed batch records, release of pharmaceutical products, and QA review and approval of product label proofs.
• Participate in continuous improvement initiatives to enhance the quality control processes and overall product quality.
• Provide input on QC methods and assist in the development of new testing procedures as needed.
• Assist with SOP training, personnel training and competency assessments for handwashing/garbing and training of quality technicians.
• Train other staff members on QC procedures and best practices.
• Stay current with new regulations, guidelines, and techniques related to quality control in 503B compounding
• Oversight of validation projects (i.e. equipment, facility, methods, and process), deviation investigations, and CAPA and Out of Specifications (OOS) investigations.
• Ensure all QC activities comply with FDA 503B requirements and other relevant regulatory bodies.
• Prepare and review QC sections of regulatory submissions.
• Under the direction of supervisor/lead, document, initiate, and investigate quality events for deviations and noncompliance.
• Conduct internal audits and gap analysis of processes, systems, and procedures.
• Assist with external, regulatory inspections.
• Maintain quality records (equipment calibration and maintenance, training, deviation and noncompliance investigations, environmental monitoring, Certificate of Analysis, clean room certification etc.).
• Maintain quality standards by approving incoming materials, in-process production, and finished products.
• Receive, store, and log in samples for testing analysis.
• Participate in investigations into any deviations, out-of-specification results, or product complaints.
• Collaborate with QA to resolve issues and prevent recurrence.
• Other duties, responsibilities and qualifications may be required and/or assigned as necessary.

Qualifications and Education Requirements

• Compounding, cGMP, and/or laboratory experience preferred
• High school diploma required and Associates or Bachelor’s degree in Health Sciences/Microbiology preferred
• Must be able to follow gowning/garbing procedures including wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles) as outlined in site SOPs
• Strong written communication and interpersonal skills.
• Demonstrated ability to work in a demanding, high performance work environment and create a positive, team-oriented culture.
• Must be well organized and detail-oriented with proven initiative and self-starter skills.
• Must possess problem solving and analytical skills
• Demonstrated ability to direct individuals and delegate responsibilities and tasks
• Excellent work ethic, including a personal drive to excel independently.
• Solid PC skills including Microsoft Office Suite (Word, Excel, Outlook)
• 20/20 Vision (either aided or unaided) as required by CGMP regulations for visual inspection of finished drug products.

Physical requirements:

• Ability to use a computer and computer-related equipment, printer/fax machine
• Prolonged periods of sitting and/or standing.
• Communicate by telephone and email
• Lift to forty (40) pounds at times.
• 20/20 vision (either aided or unaided)

Benefits:

• Health care insurance (medical, dental, vision)
• Life Insurance
• Supplemental Insurance
• PTO
• 401K matching
• Sick leave