Allyson Boseman

Responsible for support and execution of Fresenius Kabi's global quality strategy within the Wilson site with focus on general inspection readiness and continuous improvement.

• Conduct mock inspections to evaluate the site's readiness for Regulatory inspections.
• Provides leadership during Regulatory inspections.
• Lead initiatives to ensure compliance with company and regulatory requirements.
• Lead cross-functional teams on assigned projects aimed at continuous improvement and strengthening QA systems and ensuring regulatory compliance.

Responsible for oversight of all quality assurance, quality systems, and compliance functions to ensure the Wilson facility operates with regulatory and corporate requirements. The facility includes two independent manufacturing buildings for Pre-filled syringes and Standard Solution IV bags. The Pre-filled syringe building includes 2 isolator aseptic filling lines and three automated packaging lined. The Standard Solutions IV bag building includes 5 fully integrated and automated formulation, filling, terminal sterilization and packaging lines.

• Led a team of 44 QA employees with 5 direct reports covering Compliance and Quality Systems, Batch Release, Document Control, Manufacturing Quality Assurance, Laboratory Quality Assurance, and Facilities/Utilities/Equipment Qualification Quality Assurance
• Led all Regulatory inspections for the site including a Pre-Approval Inspection (PAI) for the Standard Solutions building
• Quality decision authority for the site
• Interacted regularly with Regulatory Affairs, Sales, Marketing, and Global and Corporate teams

Lead QA representative for the design, construction, and start-up of the greenfield Standard Solutions IV bag facility.

• Provided quality oversight and guidance during the design and construction of the 423,000 square foot building.
• Performed reviews of commissioning and qualification documents (URS, FDS, FAT, SAT, IQ/OQ, and PQ) for Clean Utilities systems, Formulation systems, Filling lines, Terminal Sterilizer machines, Semi-Automated Visual Inspection machines, Packaging systems, and computerized control systems (PCS, BMS, AMS)
• Developed a Manufacturing Quality Assurance team of four employees who were responsible for quality oversight during commissioning and qualification
• Member of a cross-functional team who developed SOPs and batch records
• Worked with Regulatory Affairs on FDA submissions for approval of the new facility

Provided quality oversight and guidance for Manufacturing operations for isolator aseptic filling and packaging operations and served as Responsible Person for batch release.

• Led a team of 4 MQA employees and 2 batch release employees
• Reviewed and approved manufacturing investigations
• Reviewed and approved manufacturing SOPs and batch records
• Performed final quality batch record review and disposition/release of all batches.
• Performed disposition of all incoming materials

Responsible for developing manufacturing processes for the startup of the greenfield Pre-filled syringe facility which included two isolator aseptic filling lines, two terminal sterilizers, and two packaging lines.

• Created SOPs and Master Batch Records for component prep, compounding, filling, terminal sterilization, automated visual inspection, and packaging.
• Led the Knapp Study for the automated visual inspection machine qualification
• Developed the manufacturing operator training program
• Developed the classified cleanroom gowning procedures and performed the initial gowning training for the site
• Manufacturing lead for the controlled substance / DEA program
• Responsible for the aseptic process simulation (APS)/media fill program
• Worked with Quality Assurance to develop the Deviation and CAPA system for the site
• Created the manufacturing batch record review process and performed manufacturing review of executed batch records
• Performed manufacturing investigations
• Participated in FDA inspections, including the site PAI, as a Manufacturing SME for aseptic operations, media fills, training, and batch record reviews

Held multiple positions with Abbott Labs/Hospira including:

Manufacturing Supervisor (July 2004)

• Responsible for 2 Isolator Filling Lines (1 ampoule and 1 vial) with 15 direct reports
• Supervised the media fill qualification runs for both Isolator lines
• Participated in the FDA PAI for the Isolator lines as the Manufacturing and Batch Record SME

Manufacturing Quality Assurance Supervisor (May 2002)

• Led a team of 15 Quality Assurance AQL inspectors and 5 Quality Assurance auditors
• Provided daily quality oversight and guidance for Aseptic and TS filling (5 Aseptic lines, 7 TS lines, 4 terminal sterilizers) and packaging operations (13 lines).
• Performed final quality batch record review and disposition for batch release

Aseptic Core Monitor (September 2001)

• Responsible for compliance of aseptic processes within the Aseptic area including support rooms and filling rooms and operator aseptic technique. The area included 5 filling lines (2 vial lines, 2 abboject lines, and 1 ampoule line).
• Performed daily inspections of the Aseptic cleanrooms and operator techniques
• Led the media fill program and participated in and provided guidance for aseptic technique during media fills
• Responsible for root cause analysis for Environmental Monitoring excursions (OOLs)

Environmental Monitoring Associate (June 1999)

• Performed environmental monitoring of surface samples and air within the Aseptic and TS classified cleanrooms (ISO 7 and ISO 5)
• Performed clean utility monitoring including WFI and Clean Compressed Air and Gases
• Participated in media fills by providing Microbiology guidance on aseptic technique and performing environmental monitoring of personnel, surface samples, and air
• Performed reading of media fill units