Kermit Lim
California
Overview
27
27
years of professional experience
1
1
Certification
Work History
Quality System Specialist II
ThermoFisher Scientific
West Hills, California
02.2025 - Current
- Transplant Diagnostics Support
- Process initiated NCR’s to closure through EDMS (MasterControl)
- Perform risk assessments for NCRs based on frequency of occurrence and product/process impact
- Product disposition recommendation for impacted product/material; presenting to MRB for consensus
- Initiate/escalate SCARs due to vendor nonconformances, communicate and follow-up resolutions
- Process and closure of SCARs, review of vendor RCA, corrective actions and confirming effectiveness
- Perform Walk-thru audits as needed through production lab areas in compliance maintenance
Manager, Quality Assurance Operations
Theragent, Inc.
Arcadia, California
08.2024 - 10.2024
- Interim Manager since March 2024
- Manage team of quality personnel under Quality Systems/Compliance, Quality Operations and QA Document Control
- Monitor for Quality Management Systems (QMS) updates to ensure adherence to US quality systems and regulations
- Enforce industry trends and contribute recommendations/action plans for QMS improvement
- Engage with cross functional stake holders when changes/updates are made to QMS processes
- Evaluate information from a QA technical perspective to ensure appropriate analysis and assessment is conducted with risk prioritization
Supervisor, Quality Assurance Operations
Theragent, Inc.
Arcadia, California
09.2022 - 08.2024
- Oversee cGMP activities in support of manufacturing, final product labeling, electronic batch record review, raw materials disposition, and final product disposition activities
- Oversee cGMP QA Operations procedures in support of clinical and commercial manufacturing
- Oversee the review of documents, protocols, and reports from a quality perspective for adherence to applicable regulations
- Collaborate cross-functionally between departments (Manufacturing, Quality Control, MSAT, Facilities & Engineering) to ensure product is manufactured according to approved procedures and compliant with applicable regulations
- Lend support for Quality Operations related activities and participates in audits and regulatory inspections when required
- Interface with cross-functional teams to resolve Quality Operations related issues
Sr. Specialist, Quality Assurance
Instil Bio, Inc.
Tarzana, California
11.2021 - 09.2022
- Accession (receipt/inspection/disposition) of incoming Tumor Digest and PBMC material
- Perform Issuance and Verification of Final Product Labels
- Packout and Shipment of Final Product
- Batch Record Review and Related Documentation Review
- Ensure products are manufactured in compliance with regulatory and GMP guidelines
- Ensure product-related Quality Events (Deviations, CAPAs, NCMRs) are initiated, investigated, resolved and closed
- Investigational Product Disposition
- Cleanroom Gowning Proficiency (ISO 7 / ISO 8)
- Raw Material Release
- Update, Initiate, Author and Approve procedures and forms as assigned
Quality Assurance Specialist III
Bachem Americas, Inc
Torrance, California
01.2018 - 11.2021
- Review/Release Executed Batch Production Records
- Provide support to production personnel to ensure final product compliance per company protocols, cGMPs and FDA regulations
- Compile Lot Disposition packets for final management approval
- Quality Event Management (QEM) Coordinator for Deviations, CAPAs and NCMRs
- Issue/Review Working protocols for consistency and accuracy per validation specifications
- Production Room and Materials Dispensary Clearance for personnel use
- Product Shipment Verification
- ELPRO liberoManager product shipment temperature data logger processing for alarms
- Document Control Coordinator – Process Document Change Requests through MasterControl
- Company Certified Trainer – Annual GMP/GDP Training for Current and New Employees
Sr. Specialist, Quality Assurance
NantKwest
Culver City, California
08.2017 - 01.2018
- QA production area representative for manufacturing support
- Coordinate/facilitate production related activities
- Issuance of manufacturing production records, procedures, and labels
- Assess discrepancies and initiate Non-conformance Reports and Change Controls
- Assess and close batch and material hold events prior to drug disposition for patient use
- Drug Shipment verification/Ensure delivery of Final Drug Product to Clinical Trials medical clinic
- Coordinate and facilitate lot disposition activities
- Ensure products manufactured are compliant with regulatory and GMP guidelines
- Verify all batch related documents and compile into Final Drug Product disposition packet
- Provide support in resolving material, in-process/final product, and environmental issues
- Manage daily activities for initiation, tracking and closure of non-conformances and CAPA
- Review and disposition of raw materials and components for GMP production and lab use
- GMP/GDP training for newly hired personnel
Sr. Specialist, Quality Assurance (CDMO – API Manufacturing)
Avid Bioservices, Inc.
Tustin, California
10.2008 - 08.2017
- Review & Release Batch Production Records for In-Process Manufactured APIs & Buffer Formulations/Medias
- Raw Materials Releases per Specifications
- CGMPs per 21 CFR Parts 210-211, 11
- ICHQ7A Guidelines applicable to intermediate API manufacturing processes
- Review QC Test Reports & Cleaning Verification Records for Batch/Lot Disposition
- Review and edit SOPs, BPRs and Manufacturing Formulation Records as required
- Review Change Controls for approval
- Submit Incident Reports for Quality Review Board assessment
- Manufacturing QA (MQA) backup, assure MFG processes in real time are in compliance
- Review drug product Fill Summary, Summary of Testing & C of A’s for processed lots
- Product shipment verification of commercial API batches/clinical API/drug substance lots
- Review Validation Reports/Client Specific
- Perform daily QA responsibilities and support of other Quality Assurance functions
- Assist in training of employees on Quality Systems
- Internal audits and all other audit support functions
Quality Assurance Specialist III
BioScreen Testing Services, Inc.
Torrance, California
02.2008 - 04.2008
- Perform daily QA review and release of reports generated by receiving staff from client sample submission forms.
- Out-of-Spec (OOS) forms sign-off/log-in LIMS database
- Batch Records issue/review post completion; log-in LIMS database
- Trending of specific data for upper management weekly meetings
- Decision making responsibilities regarding sample log-in and delegation of workload within Receiving department.
Research Associate II – Biochemistry
Siemens Healthcare Diagnostics
Los Angeles, California
06.2006 - 02.2008
- Monoclonal/Polyclonal Antibody Purification using Sepharose Matrix Columns
- Immunoaffinity Purification/Gel Coupling/Biotinylation of IgG/Caprylic Acid Treatment of Serum
- BCA Assay/D-8mer Antigen Production from Whole Blood
- Spectrophotometer/UV-Vis
- R&D equipment calibration
- SRM Supplier Buyer system for purchase orders
Quality Assurance Associate – Document Control
Siemens Healthcare Diagnostics
Los Angeles, California
05.2006 - 06.2007
- Revise/Finalize R&D Batch Records for Production
- Review and revise documents (e.g. policies, procedures, specifications, batch records, SOPs, protocols, RM/MM Specifications, etc.)
- Assign Change Control, Deviation, Raw Material, SOP, Forms, and Batch Record Numbers (database entry log-in for all number assignments)
- Updates to QA database (Change Control/Deviation Log, Master Batch Record Lists, etc.)
- Assist Librarian/Clerk with archiving of DHRs, DMRs, and other documentation
- Track all documents through change control/deviation process and assists in routing documents for signature approvals
- Assist QA Director/Supervisor with various projects
- Review and approve label masters for product
- Participated in the May 2007 Department of Health Services company audit
Clinical Manufacturing Specialist/Research Associate II
AmCyte Diabetes, Inc.
Santa Monica, California
05.1998 - 03.2006
- Development of manufacturing process batch records with strict compliance to federal guidelines
- SOP draft/development for in-house processes and equipment
- Document Control/Batch Records Review
- Supervise/training of new personnel for clinical manufacturing processes, QA personnel, cGMP training on company policies and procedures
- Participation in pre-clinical/clinical transplant at Toronto General Hospital
- Participation in pre-clinical porcine islet cell xenotransplant preparation
- Lead in porcine islet collaboration with University of Pittsburgh – cell encapsulation for transplant
- Maintenance of controlled areas & equipment
- Aseptic Media/Buffer Fills
- Islet cell culture experience, techniques, characterization
- Pancreatic Islet Isolation, Purification, Quantification, Morphology Evaluation, Viability & Functionality assessment
- Porcine Islet Isolation, Purification, Quantification, Morphology Evaluation, Viability & Functionality assessment
- Islet cell encapsulation/Alginate immunobarrier capsule
- Alginate capsule strength and diffusion optimization
- Culture maintenance of alginate-encapsulated islets, 0% contamination record
Education
B.S. - Biology
California State University, Los Angeles CA
Pasadena, CaliforniaA.A. - Humanities
Pasadena City College
Pasadena, CaliforniaSkills
- Batch Records/SOP Draft & Review/Raw Materials Specifications
- Adobe Acrobat, Adobe Sign, CutePDF, Foxit PDF Editor, Scanner
- Windows 10/Windows 11/MS Office
- SharePoint/NextDocs Document Management System
- Veeva Vault Document Cloud Platform / Veeva Vault QMS, Qualio QMS
- Qualio Electronic Document Management System
- EtQ Reliance Enterprise Systems
- MasterControl Quality Management System
- Elpro LiberoManager Cloud Database for Shipment Data Logger Alarms
- Visio Pro
- MS Teams / Zoom / Skype
Certification
Certified Quality Auditor Refresher Course, American Society for Quality, Orange Empire Section 0701
Hobbies and Interests
Violinist, Piano, Tennis, Hiking
Timeline
Quality System Specialist II
ThermoFisher Scientific
02.2025 - Current
Manager, Quality Assurance Operations
Theragent, Inc.
08.2024 - 10.2024
Supervisor, Quality Assurance Operations
Theragent, Inc.
09.2022 - 08.2024
Sr. Specialist, Quality Assurance
Instil Bio, Inc.
11.2021 - 09.2022
Quality Assurance Specialist III
Bachem Americas, Inc
01.2018 - 11.2021
Sr. Specialist, Quality Assurance
NantKwest
08.2017 - 01.2018
Sr. Specialist, Quality Assurance (CDMO – API Manufacturing)
Avid Bioservices, Inc.
10.2008 - 08.2017
Quality Assurance Specialist III
BioScreen Testing Services, Inc.
02.2008 - 04.2008
Research Associate II – Biochemistry
Siemens Healthcare Diagnostics
06.2006 - 02.2008
Quality Assurance Associate – Document Control
Siemens Healthcare Diagnostics
05.2006 - 06.2007
Clinical Manufacturing Specialist/Research Associate II
AmCyte Diabetes, Inc.
05.1998 - 03.2006
B.S. - Biology
California State University, Los Angeles CA
A.A. - Humanities
Pasadena City College