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.
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.
*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.
