Corey Marsh Email & Phone Number

Boston, MA, US

Hopkinton, MA, US

Cell Therapy CDMO

Cambridge, Massachusetts, US

• Buffer & media / transduction / cell bank expansion / formulation / fill / finish / packaging and labeling operations of red blood cell therapeutics. Responsible for the quality assurance of red blood cell therapeutics.
• Environmental Monitoring Memos and Quarterly Reports
• Deviations (Levels 1, 2, 3): contamination, EM excursions, automation issues, MFG issues, visual inspection, etc.
• Corrective and Preventative Actions (to above deviations, internal audit response, etc.)
• Change Controls (scale-up, specification updates, visual inspection/particulate matter, etc.)
• Documentation Updates: Quality Assurance, Quality Control (EM), Manufacturing, Tech Transfer, etc.CAPA Owner for internal audit response to batch record review and disposition process. Authored or assisted with.

• Business established to provide standard QA services (operations, validation, auditing) for the pharmaceutical or medical device industry via C2C contracts. Business founded in August 2019; incorporated as limited.
• Buffer / Media / DS & DP Formulation
• Sterilization Cycle Records
• Cell Culture Expansion
• Fill (Isolator/RABS/ISO 5 Cleanroom/BSC)
• Finish (Liquid/Lyophilized)

Basel, CH

• Responsible for the quality assurance of various medical device endotoxin test kits, standards, etc. with tasks including the following: batch record review, visual inspection, test kit assembly inspection, Gemba.
• Observe critical manufacturing process steps, clean room behavior and adherence to defined process parameters by performing walk-throughs of production and support areas.
• Initiate project to revamp visual inspection program. Assess applicability of regulatory requirements (USP, JP, EMA, WHO) and guidance documents (PDA) to medical device products. Construct visual inspection program.
• Initiate revamp to safety for fill/finishing processing. Propose short-term/long-term changes to reduce lifting during processing (up to 80%).
• Initiate a 6S project on manufacturing mechanical chase; track tasks, due dates, and progress.

Gaithersburg, Maryland, US

• Responsible for the quality assurance of a CMO fill/finish of live virus vaccines. Review issuance of BPR, review various logbooks (EM QC/MFG), perform pre-use area line clearance of filling suite isolators.
• Review batch production records for aseptic filling, visual inspection, and labeling & packaging operations: filter integrity tests, clean-in-place, vaporized hydrogen peroxide cycles, leak tests, glove/half-suit.

Foster City, CA, US

• Responsible for quality oversight of all nine packaging lines and all chambers between two facilities (La Verne/San Dimas). Responsible for the installation, qualification, periodic records review, and requalification.
• Assisted with ten new drug product launches in 2020 for the following: oral pellet medications to cure pedatric patients with hepatitis C, solid dose rheumatoid arthritis/inflammation medications, and the first.
• Support the quality risk management (QRM) program through initiation of risk assessments. Initiate and/or update failure modes, effects, and criticality analysis (FMECA) for all packaging lines.
• Author or review/approve, as applicable, quality/manufacturing/engineering/validation documents for QA/MFG operations, design specifications and engineering assessments, and qualification paperwork (protocols/final.

Foster City, CA, US

• Perform in-process acceptable quality limit (AQL) sampling, batch record review, and support disposition/document archival activities: solid dose, vial inspection, vial packaging, and manual packaging lines (Britestock.
• Revise/Author standard operating procedures (SOPs), AQL inspection forms, batch record review checklists, manufacturing production records (MPRs), bill of matierials (BOMs), Risk Assessments (RAs), grandfather training.
• Review engineering lifecycle documents to support initial design or validation activities, as applicable. Review and approve various stages/combinations of validation protocols (i.e. IQ/CQ/OQ/PQ); executable test.
• Review and approve protocol exceptions and follow-ups for protocol generation errors, changes to test scripts and/or specification documentation, and authorize additional testing, as needed. When appropriate.
• Review and approve requirement trace matrix and computer system assessments (FDA Part 11/EU Annex 11). Review release checklists (pre-commercial change management) to prepare for the release of area/process for routine.

• Managed a small group of quality control employees, lab equipment, continuous improvement projects, documentation, and lab consumable inventory for California's largest recycled post-consumer food grade plastics (PET).
• Create and/or rewrote the entire library of work instructions (over 40 documents) for the QC team.
• Complete time study on all quality team individuals / processes to establish SMART goals.
• Implement additional safety engineering controls.

Thousand Oaks, CA, US

• Support clinical packaging and labeling operations of active/placebo drug products (vials, capsules, syringes) and various medical devices (automated/manual injection pens). Ensure compliance for thousands of different.
• Perform AQL sampling, primary and secondary label artwork approval, batch record review, expiration date assignment, audit label inventory, collect/maintain reserve samples, and perform material transactions.
• Assess risk of study unblinding of blinded clinical studies via comparison sampling.

Bethlehem, PA, US

• Perform destructive integrity testing on IV bags and maintain batch records/data sheets/controlled notebooks.
• Distribute labeling materials and manage material transactions.
• Perform rework inspections per material review board protocols and ANZI/ASQ Z1.4 charts.
• Inspect production lines and clean rooms for line clearance.
• Issue separations of material.
• Review engineering work orders.

Corona, CA, US

• Shipping and Receiving Clerk
• Physically/electronically receive, label, stock, and audit inventory.
• Prepare assembly and subassembly kits for manufacturing per Bill of Materials.
• Prepare shipping documentation and packaging for domestic and international export of equipment and spare parts. Manufacturing Associate
• Perform visual, functional, and dimensional analysis on incoming raw materials against component specifications. File paperwork to disposition approved, rejected, or on-hold raw materials.
• Assist in the manufacture of Low-Pressure RF Plasma Chemical Vapor Deposition Systems. Completed construction of various assemblies and subassemblies per specification drawings.