Director of Quality Control

Wells Pharmacy Network; Ocala (FL); On-site; USD 110,000 - 170,000; Full time

Job summary

Wells Pharmacy Network is seeking a Director of Quality Control to lead the Microbiology QC Lab, ensuring compliance with FDA, DEA, and 503A/503B requirements. The role supports multiple sites in Florida, Tennessee, and Dallas, TX with data, reports, and research.

The position emphasizes method development, policy writing, and supervision of Batch Record Review and Disposition activities, as well as overseeing investigations and CAPA processes to improve quality and efficiency.

Qualifications

• Bachelor's degree in Microbiology, Biology or related field is required or equivalent experience.
• Demonstrated microbial knowledge in support of product release testing, contaminations, and investigations.
• Knowledge of QA processes such as CAPA, non-conformance, deviation, document management, change control, and product disposition.

Responsibilities

• Maintain the Microbiology QC Lab in full compliance with FDA, DEA and 503A/503B requirements.
• Identify and implement improvements to Quality Systems, processes, procedures, and training.
• Perform root cause analyses and CAPA effectiveness checks for products and processes.
• Review sterility, potency results and write investigations, specifications, batch records, and SOPs.
• Define and track lab performance metrics including non-conformances and turnaround times.
• Collaborate with cross-functional groups across FL, TN and Dallas sites.
• Train and coach team members in microbiological methods and regulatory requirements.

Skills

Quality control

CAPA

Root cause analysis

Microbiology methods

Education

Bachelor's degree in Microbiology, Biology or related field

Job description

The Director of Quality Control maintains the Microbiology QC Lab function in full compliance with FDA, DEA and 503A, 503B compounding pharmacy requirements. Supports the Business Units in FL, TN and Dallas, TX by providing necessary data, writing reports, and conducting research on various topics. Stays updated on best practices and quality trends and regulatory requirements. Responsible for specifications and other quality engineering activity. Supports Research and Development projects, writes protocols, and reports. This position supervises the daily function in Batch Record Review and Disposition group and assists with the release of materials, components and drug products. In addition to overall Microbiology QC lab tasks, this position focuses on method development and method suitability for potency applications.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Maintain the QC Microbiology Lab and function in full compliance of the labs to enhance throughput efficiency and compliance with FDA, DEA and 503A, 503B requirements
• Identify and implement improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes
• Ensure root cause analyses, CAPA effectiveness checks and risk analysis for products, processes and systems
• Review EM, sterility, potency test results, and write investigation reports, specifications, batch records, qualification/validation protocols and reports and SOPs
• Define, track, trend, and document laboratory performance and quality metrics, including non-conformances, tum-around time, capacity, and return on investment, for evaluation of laboratory performance
• Review Analytical Methods and Specifications, Validation Protocols, Deviations, Investigations, Impact Assessments and other forms of Quality documentation as assigned
• Provide assistance in performing the investigations and research for all QC related investigations as well as CAPA, cost analysis, monitoring, reworks, and appropriate documentation;
• Ensure proper oversight and management for protocol development, report writing, trend report and deviation management
• Collaborate with cross functional groups, working with FL, TN and Dallas, TX operating sites
• Train and coach team members for microbiological methods, and regulatory requirements

• perform hands-on testing working with team members as required

• Act as Subject Matter Expert (SME) for microbiology within the organization focusing on continuous improvement
• Collaborate with third party testing labs, API suppliers for timely execution of tasks
• Assist in developing and strengthening quality culture of the organization
• Take responsibility for the analysis and interpretation of data and provide guidance in the correction of discrepancies. Ensure data is established in compliance with proper methods.
• Other duties may be assigned by the supervisor.

SUPERVISORY RESPONSIBILITIES:

Manages employees in the Quality Control Department. Is responsible for the overall direction, coordination, and evaluation of these units. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

EDUCATION AND/OR EXPERIENCE:

• Bachelor's degree in Microbiology, Biology or related field or equivalent work experience required
• Demonstrated applied microbial knowledge in support product release testing, contaminations, and investigations. Experience with microbiological risk assessments preferred.
• Must have deep knowledge and appropriate use of key Quality Control processes such as Corrective and Preventive Actions (CAPA), non-conformance, deviation, document management, change control systems, and product disposition processes, including the

ability to make recommendations for the improvement of processes to achieve regional/global standardization.

• A fundamental, working knowledge of safety, quality systems, and quality Control concepts is required including the application of current Good Manufacturing Practices, DEA, and 503A and 503B requirements
• Strong problem solving and decision-making skills as well as the ability to master complexity and influence in others is required.
• Good technical writing and project management skills are necessary. Experience validating microbiology methods are highly desired.