Quality Assurance Specialist, 503B

It's more than a career, it's a calling.

MO-SSM Health Mission Hill

Worker Type:

Regular

Job Summary:

Responsible for quality assurance and regulatory compliance with pharmaceutical compounding at the organization. Ensures site operations and processes are well integrated, meeting all regulatory requirements including Federal Drug Administration (FDA), Drug Enforcement Administration (DEA), United States Postal Service (USPS) and the Board of Pharmacy requirements and industry best practices. Acts as a communicator, facilitator, and translator of the organizational quality expectations. Ensures pharmacy staff have the knowledge to effectively accomplish an engaged quality workforce.

Job Responsibilities and Requirements:

PRIMARY RESPONSIBILITIES

• Drives and maintains regulatory compliance under relevant regulatory areas for pharmaceutical compounding and outsourcing, including 503b and other regulations. 
• Maintains all pharmaceutical compounding quality systems and ensure compliance with Current Good Manufacturing practices (cGMPs). Ensure each lot of compounded sterile products remains quarantined until sample testing has been completed/released and suspends operations if not in compliance. 
• Establishes compliance monitoring system designed to prevent, track and trend compliance related issues. Drafts and reviews quality-related documents (e.g., standard operating procedures, forms, logs, training records, audits, deviations, etc.). 
• Maintains product retains and label control, maintains stock, prints labels for production, conducts label reconciliation, and verifies materials issued for packaging.  
• Performs Acceptable Quality Level (AQL) inspection for in-process and finished product. Responsible for inspection, documentation, and acceptance/rejection status.  
• Reviews and brings concerns to leadership of any changes or need for change that impacts product quality. Ensures that quality related complaints, deviations, and events are investigated and resolved. 
• Ensures all samples are appropriately analyzed and the results are reported. Maintains all quality related records. Ensure a program of continuous quality improvement is in place.  
• Coordinates communication as necessary with federal and state regulatory agencies (DEA, FDA, applicable state agencies) regarding regulatory requirements pertaining to pharmaceutical compounding. 
• Works in a constant state of alertness and safe manner. 
• Performs other duties as assigned.

EDUCATION

• High School diploma/GED or 10 years of work experience

EXPERIENCE

• Three years' industry experience, with one year in quality assurance or control

PHYSICAL REQUIREMENTS

• Frequent lifting/carrying and pushing/pulling objects weighing 0-25 lbs.
• Frequent sitting, standing, walking, reaching and repetitive foot/leg and hand/arm movements.
• Frequent use of vision and depth perception for distances near (20 inches or less) and far (20 feet or more) and to identify and distinguish colors.
• Frequent use of hearing and speech to share information through oral communication. Ability to hear alarms, malfunctioning machinery, etc.
• Frequent keyboard use/data entry.
• Occasional bending, stooping, kneeling, squatting, twisting and gripping.
• Occasional lifting/carrying and pushing/pulling objects weighing 25-50 lbs.
• Rare climbing.

REQUIRED PROFESSIONAL LICENSE AND/OR CERTIFICATIONS 

• None

Work Shift:

Day Shift (United States of America)

Job Type:

Employee

Department: