Quality Specialist

Purpose

The purpose of this memorandum is to justify the addition of dedicated Quality Assurance In-Process (QAIP) personnel to support the upcoming 503B operations at the Tamarac manufacturing site. The expansion of sterile manufacturing activities into 503B operations will significantly increase the level of Quality oversight required to ensure compliance with current Good Manufacturing Practice (cGMP) regulations, maintain product quality, and support uninterrupted manufacturing operations.

Current State

The Quality Operations department currently staffs one QA In-Process (QAIP) Specialist per manufacturing shift (two working shifts). While this staffing model has been adequate to support existing operations, each QAIP is responsible for numerous critical quality oversight activities throughout the facility, including but not limited to:

• Room release prior to manufacturing operations
• In-process inspections during manufacturing
• Review of manufacturing area and equipment logbooks
• Verification of entries within executed in-process batch records
• Routine Quality walkthrough inspections of manufacturing areas
• Collection of retention samples
• Oversight of line clearance activities
• Verification of cGMP compliance during manufacturing operations
• Support of deviation identification and immediate quality assessments
• General Quality presence on the manufacturing floor

These activities require continuous interaction with Manufacturing personnel and must be performed in real time to ensure compliance with internal procedures and regulatory expectations.

Impact of 503B Operations

The implementation of 503B operations will substantially increase the demand for Quality oversight within the manufacturing environment. Unlike current operations, 503B production will require increased QA presence throughout the manufacturing process due to the nature of compounded sterile drug production and the heightened regulatory expectations associated with aseptic processing.

Additional QA oversight will be necessary to support:

• Continuous monitoring of critical manufacturing activities
• Increased verification of aseptic practices and operator compliance
• Enhanced oversight of environmental controls and cleanroom practices
• Timely review and documentation of in-process activities
• Immediate assessment and escalation of quality events
• Increased coordination with Manufacturing during production campaigns
• Verification of process compliance throughout the manufacturing operation

These responsibilities cannot reasonably be absorbed by the current QAIP staffing model without negatively affecting routine Quality oversight across the remainder of the facility.

Additional activities

• The role of the Quality and Compliance department has been expanded to include production supply supplier qualification.
• In addition to these activities, Quality needs to begin establishing the Annual Product Quality Review system and implementing a continuous monitoring program.

Operational Risks

Maintaining only one QAIP per shift while introducing 503B manufacturing presents several operational and compliance risks, including:

• Reduced Quality presence on the manufacturing floor
• Delays in completion of required Quality inspections and verifications
• Increased potential for missed or delayed identification of quality events
• Reduced responsiveness to Manufacturing support requests
• Increased workload leading to personnel fatigue and higher potential for human error
• Limited flexibility to support concurrent manufacturing operations
• Insufficient coverage during employee absences, meetings, investigations, or training activities

Additionally, the Tamarac site continues to execute multiple operational projects and process-improvement initiatives, further increasing the daily workload of QAIP personnel. As manufacturing operations continue to expand, existing resources are approaching maximum capacity.

Qualifications

Education

B.A. /B.S. degree and a minimum of one to three years of related experience. Must be familiar with overall pharmaceutical manufacturing and quality systems/process.

Knowledge, Skills and Abilities

• Strong knowledge of cGMP regulations and pharmaceutical quality systems.
• Experience in manufacturing processes, aseptic processing, and documentation.
• Attention to detail with a commitment to accuracy and data integrity.
• Ability to manage multiple assignments in a dynamic, fast-paced environment.
• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
• Strong interpersonal and collaboration skills, with the ability to work effectively across departments.
• Ability to interpret and follow written procedures and regulatory requirements.