Ashley Norman

· Supervises microbiology personnel, ensuring adherence to performance standards.
Established annual targets and tracked progress to meet organizational goals.

· Manages the testing schedules of both project and routine samples to meet required timelines.

· Maintains high standards of safety and efficiency in all work performed.

· Enhances technical proficiency within the Microbiology Department via ongoing training and development initiatives for Microbiology personnel.

· Interacts with federal, state and local officials during regulatory inspections.

· Prepares the Microbiology Laboratory for customer audits.

· Addresses customer inquiries regarding quality concerns.

· Supports microbial investigations and root cause analysis.

· Reports the results of out-of-specification and failure investigations to upper management.

· Sets Microbiology Compliance policies.

· Evaluates, updates, and maintains currency of SOPs and methods pertaining to Microbiology Department.

· Approves and rejects all Microbiology SOPs, methods, protocols and validations.

· Responsible for all microbial data generated in the Microbiology Laboratory.

· Provides data for the Annual Reports for commercial products.

· Provides Business Development team with information for Quotations/QARs for billing microbial services.

·Facilitated communication and implementation of Human Resources policies within Microbiology Department.

· Ensures accurate documentation of employee performance and administers appropriate discipline in collaboration with Human Resources.

· Support release of raw materials, in-process, finished product by reviewing GMP documents (data, notebooks, certificate of analysis, validation/qualification reports, etc) for compliance to internal SOPs and approved test methods as well as technical accuracy

· Read and understand test methods from multiple compendia (i.e. USP/NF, EP, JP), internal Catalent methods, or customer/supplier methods

· Support customer validations and suitability by reviewing GMP documents, drafting reports and responding to customer inquiries.

· Participate in customer/agency audits as necessary by giving tours, answering auditor questions and supplying requested information

· Assisted in training QC Microbiologists

· Assisted in laboratory investigations, SOP revisions, CAPAs and audit responses

· Draft or review standard operating procedures as needed

· Scheduled the Micro Department to ensure On Time Delivery of product to the customer and raw materials to the manufacturing floor.

· Routinely performs environmental monitoring, including: viable particulates, non-viable particulates, product contact surfaces, compressed air, nitrogen, and water.

· Trained multiple new hires and other personnel in environmental monitoring and various other basic lab skills.

· Main reviewer for raw materials and finished goods.

· Proficient in Microbial Enumeration and Tests for Specified Microorganisms for raw materials, finished goods and stability.

· Routinely executes a variety of basic microbiological testing as assigned. Including gram stains, subculturing, growth promotion, and morphological assessments.

· Regularly executes release and stability testing for excipients, drug substance, and drug product via: Microbial Enumeration, Tests for Specified Microorganisms, and Antimicrobial Effectiveness Testing.

· Approved GMP/GDP document reviewer.

· Routinely executes a variety of basic microbiological testing as assigned, including: pour-plating, membrane filtration, dilutions, growth promotion testing, plate enumeration, and morphological assessments.

· Routinely reviews and revises testing procedures, SOPs, and testing forms.

· Sole personnel in charge of ordering and maintaining inventory for the QC Microbiology Department.

· Assisted in multiple systems validation/qualifications, including: Compressed Air, Nitrogen, Manufacturing Clean Rooms, Purified Water, and Autoclave.

· Trained multiple new hires and other personnel in basic microbiological testing and compendial testing.