The Manager, Quality Assurance-Document Control will direct all activities within the Document Control department to ensure the quality, integrity, and control of company records/documentation. This position is accountable for the efficient and effective management of Document Control procedures to meet 21 CFR Part 111, Production, and cross-functional requirements. As a key team member in the Quality Control Unit (QCU), the role will develop and implement strategies to ensure continuous improvement of Document Control processes, procedures, accuracy and quality. The position will participate in the transition to an automated document control system.
- Responsible for directing assembly of all Batch Production Record (BPR), Document Revision Request (DRR), team function and supervision, and records keeping activities within the Quality Assurance-Document Control department.
- Routinely collaborate with Production/Scheduling to accurately determine capacity, immediate needs, and daily/weekly goal-setting.
- Build and manage Document Control team, develop and motivate staff, and effectively delegate to meet high priority objectives.
- Screen, interview, and onboard new employees. Conduct training and assessment to ensure that all staff are cross-trained on critical tasks.
- Supervise staff and effectively manage performance evaluations, disciplinary issues, and administrative duties.
- Effectively track and report BPR, Purchase Order (PO), and DRR statuses to all departments.
- Establish, report, and improve upon department Key Performance Indicators (KPIs).
- Report department strategy, performance metrics, immediate needs, and relevant information to the senior leadership team.
- Ensure documentation/records compliance with all FDA, GDP, GMP, GxP, and internal procedure standards.
- Interface with other functions in the resolution of issues or concerns related to Document Control.
- Plan and implement corrective action strategies, procedure changes, and continuous improvement initiatives.
- Integrate data sets and forms through the use of MS Office
- Participate in cross-functional continuous improvement activities.
- Serve as the Document Control department representative for cross-functional meetings and FDA/Third Party audits.
- Identify, establish, and maintain effective Document Control department standards, processes, and policies.
- Develop and manage data migration/integration to automated document control system.
Required Skills and Experience
• BS degree in Life Sciences is preferred. BS in English, Communications, Business, or equivalent is acceptable with appropriate prior experience in Quality Assurance / Document Control
• 4+ years of document handling or equivalent experience; experience with controlled and regulatory documents
•2+ years of management or supervisory experience in a regulated office environment
•Computer proficiency a must (Microsoft Excel, Word, PowerPoint, Outlook, Adobe Acrobat Pro, Training Manager, etc.).
Expertise in Excel is essential.
•Knowledge of FDA Good Manufacturing Practices and Good Documentation Practices a must
•Must be able to keep up with a fast-paced environment, where demands change frequently, and have the ability to learn new systems quickly
•Excellent communication and technical writing skills
•Candidates must have very strong organizational skills, be detail oriented, and be self-motivated
•Experience issuing batch production records and inventory pick lists
•Excellent communication, motivational, team building, time management, and prioritization skills.
•Strong problem solving and analytical skills.
•Continuous improvement experience (ex: Kaizen, lean/agile methodologies, etc.) preferred.
•Ability to rapidly change group priorities when needed without disruption.
•Other duties or tasks as assigned by upper management.
•Preferred knowledge of 21 CFR Part 111 and ISO 17025 Certification Environment
•Experience with electronic laboratory information management systems (LIMS) is preferred (StarLIMS by Abbott Informatics is our in-house system)
•Experience with Enterprise Resource Planning (ERP) software is preferred (systems such as Oracle, SAP, Microsoft Dynamics, Infor, Deacom, MAXFood, etc.)
•Familiarity with cGMP, GDP, and relevant FDA regulatory agencies for the Nutritional Supplement and Quality Control Laboratory industries
•Experience in implementing electronic document systems and workflow including Part 11 compliance
•Project Management experience