A suitable combination of education combined with 2 years of experience in sterile pharmaceutical compounding, quality control and/or quality assurance.
Manages all quality and production aspects associated with the development and manufacture of compounding pharmaceuticals, including:
• Maintaining compliance with USP <797> and 21 CFR Parts 210 and 211.
• Review and assess regulatory and internal requirements, from a quality and compliance standpoint, associated with the development and manufacturing of a product, including:
o Review and approval of manufacturing/compounding worksheets, analytical methods, specifications, validation protocols and reports, and batch records.
o Write new and update current Standard Operating Procedures.
o Review and approve for release batch records for manufactured batches.
o Includes ensuring proper potency and microbiology testing is completed and results are within specification
o Maintaining an internal audit program.
o Maintaining a change control system.
o Maintaining a Corrective and Preventive Action program.
o Management of a complaint system.
o Management of validation program.
• Provide ongoing support and management of the overall quality system.
• Scheduling and maintaining compliance of all environmental monitoring
• Procure all materials necessary for all compounding /manufacturing activities
o Includes ordering of all chemicals and supplies needed for production schedule.
• Schedule Production
• Manage Production
o Includes analyzing past sales to determine proper size and frequency of batch production.
• Perform and/or participate in USP 797 inspections of contract facilities.
• Continually monitor and evaluate all process for improvement
• Perform and evaluate investigations, including Out-of-Specification investigations.
• Keep management informed of quality issues.
Qualifications: In order to perform this job effectively, the individual must possess the following minimum skills, knowledge, and experience:
Interpersonal Skills: This position requires daily contact with internal and external clients. Such contact may be written and verbal.
Communication: The ability to read, analyze, and understand technical information describing formulation, manufacturing processes, and quality control.
The ability to interpret and respond to questions pertaining to manufacturing, support processes,and quality control.
Reasoning Skills: The position requires the ability to define and understand problems, collect data, determine the facts, and draw conclusions and/or make recommendations
Organizational Skills: Must be able to prioritize the work and manage the projects in a timely and effective manner.
Computer Skills: The individual in this position must have the ability to use a personal computer for word-processing (correspondence) and for accessing e-mail communication. Additional skills, such as experience with Microsoft Office and the use of project management software are also required.
Supervisory Responsibilities: Supervisory responsibilities as projects necessitate.
Good diplomatic skills are required.
Flexibility: Must be sufficiently flexible to work on a variety of assignments which may or may not fall within this job description
Salary: $110,000 - $150,000 (DOE)