Quality Assurance Document Control Supervisor

Essential Functions

• Provide training on document control processes and systems
• Prepare quality documentation and reports by collecting, analyzing, and summarizing information and trends
• Identify process improvements and implement changes to enhance efficiency and effectiveness
• Create, revise, and approve documents, including, but not limited to, SOPs, batch records, deviations, CAPAs, and change controls
• Evaluate completed batch records and other relevant information to ensure procedures were followed, product tests performed appropriately and acceptance criteria met
• Partner cross functionally to collect trend data and present to management
• Identify trends in the relevant industries and recommend improvements
• Collaborate to ensure that the quality systems are in a state of control
• Assist with managing the document control system to ensure the integrity and accessibility of documents
• Participate in internal and external audits, providing documentation and support as needed
• Prepare and review data packets and Certificates of Analysis for product release
• Escalate communications regarding issues or concerns appropriately
• Other duties as assigned

Supervisory Responsibilities

• Directly hire and lead a team of specialists
• Foster a positive and productive work environment, providing guidance, coaching, and mentoring as needed to achieve a culture of excellence and collaboration
• Conduct regular 1:1's to address performance, feedback and relationship building
• Identify training and development needs within the team and facilitate as able

Experience and Necessary Competencies

• Bachelor's degree (BS or BA) in a biological Science or equivalent experience required
• 3+ years of experience with the US FDA cGMPs required, preferably in a commercial compounding outsourcing facility, at least one of which must be in a Supervisory capacity
• Knowledge of compounding techniques and controlled environments
• Knowledge of appropriate materials and conditions
• Knowledge and experience with electronic document management systems (Dot Compliance experience preferred)
• Demonstrated ability to identify potential adverse issues
• Excellent organization and documentation skills with a strong attention to detail and a commitment to accuracy
• Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus
• Proficient written, verbal and oral English communication skills are required
• Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel

Competencies

• Process Management: Understands and improves processes to ensure work is completed efficiently, effectively, and in compliance with quality and regulatory requirements
• Managing & Measuring Work: Establishes clear responsibilities, goals, and performance expectations while monitoring progress, results, and accountability
• Problem Solving: Uses sound analysis and logical thinking to identify issues, evaluate root causes, and implement effective solutions
• Directing Others: Provides clear direction, communicates expectations, organizes work effectively, and supports team members in achieving results
• Written Communications: Communicates clearly and accurately in writing, ensuring information is documented and conveyed effectively across a variety of formats and audiences

Physical Requirements

• Ability to stand or sit for extended periods of time
• Ability to lift, push and pull up to 25 pounds periodically