Quality Assurance Document Control Supervisor

Job Description

Job Description

The Quality Assurance Document Control Supervisor reports to the Quality Assurance Document Control Manager and oversees document control operations, including document issuance/review/retention/archival, batch release documentation, and final product release review. This role leads the document control team, drives process improvements through trend analysis, and partners cross-functionally to ensure compliance with regulatory requirements and company quality standards. 

Why Join Leiters Health?

Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team!

At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.

• Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
• Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
• Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
• Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
• Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.

 

Who We're Looking For:

We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!

Essential Functions:

This description is intended to be illustrative of the major duties performed by the employee assigned to this position. 

• 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. 

Benefits:

• Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
• Flexible Spending & Health Savings Accounts (FSA & HSA) available
• Dental & Vision insurance 
• Employer Paid Life Insurance & Employee Assistance Program
• Short Term & Long-Term Disability Insurance
• Up to 4% 401K Matching (100% vested on day one!)
• Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
• $5,250 Annual Tuition Reimbursement after 6 months
• $1,000 Referral Bonus Program with no limit
• Eligible for annual bonus program 

 

  Timeline:  We will be accepting applications on an ongoing basis until position is filled.