COREY ADAMS
Lexington,KY
Summary
I'm a seasoned Quality Assurance and Regulatory Compliance professional with nearly a decade of experience in the cGMP pharmaceutical industry. My background encompasses a diverse range of prior experience in Operations, Quality Assurance, Quality Systems, and Regulatory Compliance roles.
My career is marked by a strong commitment to continuous Quality improvement with a proven track record leading internal and external audits, resolving compliance gaps, and driving cross-functional projects that enhance operational efficiency and maintain quality standards.
Holding a Bachelor’s degree in Neuroscience with additional post-baccalaureate studies in Business, Accounting, Public Health, and Immunology, I bring a well-rounded and analytical approach to problem-solving. My technical skills are complemented by advanced knowledge of industry-standard software such as Trackwise, CalMan, J.D. Edwards,SAP, as well as programming tools like PowerBI for automated data analysis and reporting.
In every role, I aim to leverage my expertise to foster a culture of quality, drive process excellence, and contribute to the successful delivery of high-quality products that meet or exceed regulatory and customer expectations.
Overview
8
8
years of professional experience
8
8
years of post-secondary education
Work History
Sr. Compliance Specialist
PIRAMAL PHARMA SOLUTIONS, INC
04.2022 - Current
- Lead auditor for the site cGMP internal audit program
- Responsible for performing system audits, issuing audit reports for findings of non-compliance and recommendations for improvement
- Primary audit host (auditee) and SME for external audit program (client, certification, and regulatory audits)
- Responsible for hosting all external audits, drafting responses and CAPA plans, and monitoring closure of client commitments
- Responsible for review and approval of preventive and corrective actions in the Trackwise Quality System
- Lead internal auditor responsible for management of self-inspection program and training site employees
- Responsible for managing site inspection readiness program and PAI program activities
- Responsible for performing site assessments for emerging regulations, field alerts, recalls, FDA Form 483s, Warning Letters, and statements of non-compliance with cGMPs
- Responsible for gap assessment and remediation projects to support alignment with regulatory guidance criteria applicable US, EU, and various ROW countries.
Sr. Quality Assurance Specialist
PIRAMAL PHARMA SOLUTIONS, INC
- 04.2023
- Successfully led site QMS transition from paper to Trackwise, assisting with Trackwise workflows, queries, and drafting new procedures
- Transitioned Change control, Deviation, and CAPA procedures to new Trackwise system QMS
- Provided SME support on Trackwise processes and workflow during QMS transition phase
- Independently rolled out new automated QMS reporting process, reducing the allotted time for data and metric pulls by 90%
- Successfully implemented a new inspection readiness program for the manufacturing site, which involved creating audit checklists, selecting and training cross-departmental SMEs, performing pre-audit walkthroughs, communicating observations / near misses, and implementing corrective and preventive actions
- Participated in client, regulatory audits and onsite client interactions as Quality Assurance SME
- Provided Quality approval on master records including Master Calibration Records, Standard Operating Procedures (SOPs), Protocols, Client Specific Records, and other GMP documents
- Reviewed and audited production batch records to ensure adherence to policies, SOPs, and cGMP requirements
- Responsible for supporting Manufacturing QA team via executing the responsibilities of line clearances, AQL, and real-time record review in the event Quality Assurance Specialists and Sr
- Specialists are unavailable
- Responsible for leading compliance walkthroughs and audit prep activities for client, corporate, and regulatory audits.
Quality Systems Specialist
CATALENT PHARMA SOLUTIONS, LLC
03.2021 - 08.2022
- Responsible for timely completion of Annual Product Review reports (APR’s) and supporting Annual Review submission requests for all commercial finished products manufactured, tested, and packaged by the company
- Responsible for reviewing all product-specific changes to the client’s manufacturing, process, equipment, specification, test method, validation, and stability documentation and drafting APRs for the customer to assess and submit changes to the FDA
- Responsible for statistical analysis and process performance/capability assessments for commercial product CQA’s (assay, dissolution, LOD, etc.)
- Identified, proposed, and tracked completion of changes to validated processes based on in-process and finished product test results
- Coordinated with internal and external analytical and microbiology laboratories to review and report CMC changes to existing processes, effective documents, and analytical/stability results to meet FDA Annual Report requirements
- Responsible for trending Regulatory metrics and Quality Systems metrics for presentation and feedback in Management Review meetings.
Regulatory Compliance Specialist
CATALENT PHARMA SOLUTIONS, LLC
03.2019 - 03.2021
- Self-Inspection Program (Lead Internal Auditor) – Lead internal auditor with responsibility for management, oversight, and compliance of internal audit program
- Certified ISO 13485:2016 Internal Auditor – Medical Device
- Successfully led the self-inspection program as the site lead internal auditor
- Led twenty (20) site internal audits, mock inspections and mock recalls with a trained and selected audit team
- External Audit Program (Lead Auditee) – Led external audit program activities as primary audit host and Regulatory SME in customer, regulatory, and certification audits
- Performed lead auditee activities for over fifty (50) external audits
- All audit outcomes were favorable and resulted in approval / requalification of the site (No 483s or critical observations)
- Successfully obtained initial ISO 13485 and USP certification as auditee
- Led regulatory inspections as audit host during FDA and Russian Ministry regulatory inspections
- Created a new state licensure program to support interstate shipments for new business
- Successfully filed initial applications for manufacturer / distributor to all 50 US States and created procedure for tracking and processing license renewals
- Successfully qualified new 50K sq
- Ft
- Warehouse for raw material and finished product storage through applying and passing regulatory inspections from KY Board of Pharmacy and FDA
- Successfully completed regulatory gap assessments focused on compliance to Combination Product standards and Design Control activities per 21 CFR Part 4, 820, 210 & 211
- Successfully completed regulatory gap assessments focused on Dietary Supplement & Food Manufacturing regulations per 21 CFR Part 111 and 117.
Quality Assurance Specialist
PIRAMAL PHARMA SOLUTIONS, INC
03.2018 - 03.2019
- Led and supported QMS improvement projects for CAPA, Deviation, Complaint, and Change Management systems
- Participated in self-inspection and mock recall activities as an internal auditor
- Completed audit response reports and coordinated between departments to provide audit responses and complete actions for customer and regulatory observations
- Reviewed and approved Deviations, LIR’s, Calibration Failures, Market Complaints, & Environmental Monitoring Excursions
- Responsible for driving Quality ownership and continuous improvement efforts for Management Review meetings in coordination with Quality leadership
- Responsible for driving Quality ownership of meeting content, identifying action items, generating metrics and visualizations, and assuring Management Review meetings were held in compliance with corporate, regulatory, and site SOP requirements
- Responsible for issuing Master Batch Records and finished product labels, performing line clearances, product inspection, auditing GMP documentation, and approving release of equipment and API/raw materials for use.
Cell Processing Technologist II
INSTITUTE FOR CELLULAR THERAPEUTICS
11.2017 - 03.2018
- Promoted to Cell Processing Technologist II based on cGMP experience and an increase in critical responsibilities
- Assisted in process improvement of Master Batch Record procedures
- Led a batch record execution team that reduced manufacturing time by over 40% compared to previous manufacturing durations
- Responsible for conducting deviations and non-conformances, implementing CAPAs, and performing effectiveness checks.
Research & Inventory Technologist I
INSTITUTE FOR CELLULAR THERAPEUTICS
06.2016 - 11.2017
- Manufactured novel hematopoietic stem cell blood products in Phase II and Phase III clinical trials as a novel treatment for clinical subjects receiving living kidney transplants
- Primary responsibilities were focused on manufacturing activities of a novel stem cell product and manufacturing platform technology in an ISO-7 compliant cleanroom facility utilizing cGMP Aseptic Technique procedures
- Responsible for reporting and improving upon regulatory commitments and compliance concerns as related to inventory management/control and batch production procedures
- Responsible for programmatic organization activities such as equipment maintenance, preparation and revision of SOP's, and facility monitoring and maintenance
- Responsible for placing, cataloging, and reconciling purchase orders, shipping and receiving of critical raw materials, and identity testing of raw materials in a cGMP environment
- Responsible for forecasting inventory demands across multiple departments to improve upon the standards that supplies and reagents are purchased according to budget and usage rates.
Education
High School Diploma -
Lone Oak High School
Paducah, KY 08.2008 - 05.2012
Bachelor of Science - Neuroscience
Centre College
Danville, KY 08.2012 - 05.2016
Skills
- Quality and Regulatory Management
- Quality Management System
- Risk Assessment and Mitigation
- Root Cause Analysis
- Internal and External Audits
- Trend Analysis & Data Modelling
- Aseptic Behavior & Technique
- Continuous Improvement
Technicalskillsandexperience - Skills
Significant expertise with the following computer systems and software: QMS: Trackwise, Minitab Statistical Analysis, Documentum EDMS, ENSUR EDMS, ComplianceWire, CalMan. ERP: J.D. Edwards and SAP. Other: DAX, Python, Microsoft Office, Teams, Power BI, Excel, Powerpoint, Word, & Sharepoint. Highly experienced with statistical process control techniques, process capability & performance assessments, data trending, data modelling and presentation. Experienced with protocol execution and program requirements for CSV, Data Integrity Compliance, 21 CFR Part 11. Certified ISO 13485:2016 Internal Auditor – Medical Device
Summaryofqualifications - Qualificationsandkeyachievements
Ten (10) years of combined cGMP manufacturing experience in Quality Assurance, Quality Control, Quality Systems, Regulatory Compliance, and Manufacturing roles. Direct experience with the development, implementation, and oversight of regulatory & compliance activities to comply with regulatory and certification requirements (FDA, EMA / MRA, PMDA, RMIT, USP, ICH, PICS, & ISO). Significant experience with regulated GxP manufacturing, testing, packaging/labelling, and warehousing operations for a variety of regulated finished products and dosage forms: Sterile Injectables (Aseptic), Cell Therapy (Aseptic), Biologics, Oral Solid Dose (Rx & OTC), Medical Device, Combination Product, Food & VMS Supplements. Experienced with management and continuous improvement of Quality Management Systems (QMS): Led multiple paper and Trackwise QMS improvement projects to re-design and simplify Deviation/LIR, CAPA, Complaint and Audit programs. Led multiple efforts to design and implement lean improvements to Change Management programs aimed at reducing complexity, implementing methods to track KPI’s, and adding regulatory assessment requirements. Took initiative to learn Python and PowerBI DAX code to automate metric reporting, allowing for use of centralized dashboards with real-time statistics on key KPIs and metrics. Significant audit experience as both a lead internal auditor and primary audit host with oversight to external and internal cGMP audit programs. Five (5) + years served as primary audit host (auditee) in customer and regulatory audits; All audits received successful outcomes and re-qualification status with no critical observations, 483’s, or VAI/NAI outcomes. Five (5) + years of experience as lead auditor and auditee for internal audit programs. Responsible for oversight of self-inspection program, performing mock inspections and recall activities. Successfully resolved compliance gaps and obtained initial ISO 13485 and USP certifications and re-certifications as auditee.
Timeline
Sr. Compliance Specialist
PIRAMAL PHARMA SOLUTIONS, INC
04.2022 - Current
Quality Systems Specialist
CATALENT PHARMA SOLUTIONS, LLC
03.2021 - 08.2022
Regulatory Compliance Specialist
CATALENT PHARMA SOLUTIONS, LLC
03.2019 - 03.2021
Quality Assurance Specialist
PIRAMAL PHARMA SOLUTIONS, INC
03.2018 - 03.2019
Cell Processing Technologist II
INSTITUTE FOR CELLULAR THERAPEUTICS
11.2017 - 03.2018
Research & Inventory Technologist I
INSTITUTE FOR CELLULAR THERAPEUTICS
06.2016 - 11.2017
Bachelor of Science - Neuroscience
Centre College
08.2012 - 05.2016
High School Diploma -
Lone Oak High School
08.2008 - 05.2012
Sr. Quality Assurance Specialist
PIRAMAL PHARMA SOLUTIONS, INC
- 04.2023
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