Marco P. Hassell
Quality Assurance Manager, Sterile injectables
Rockville, MD · (301) 555 0114 · name@example.com · linkedin.com/in/marcophassell
Key Qualifications
EXPERIENCE
Thirteen years in pharmaceutical quality with five years managing quality assurance staff
INDUSTRIES
Sterile injectables, aseptic fill finish, contract commercial supply
SPECIALTIES
Batch disposition, aseptic process review, deviation and corrective and preventive action management
SYSTEMS
TrackWise, Veeva Vault, laboratory information management system, Empower
CREDENTIALS
Certified Quality Auditor with the American Society for Quality
TEAM
Eight quality assurance specialists across two shifts
EDUCATION
Bachelor of science in microbiology, University of Maryland
Results at a Glance
1,240
Lots of sterile
483,
Answered inside
61 days
By rewriting
44%
Eighteen months using
Executive Summary
Quality assurance manager at a sterile injectables site running under current good manufacturing practice. Thirteen years in pharmaceutical quality, five of them leading people. Owns batch disposition for aseptic fill finish product, chairs the deviation review board, and hosted the pre approval inspection that cleared the site for commercial supply.
Signature Achievements
- Released 1,240 lots of sterile injectable product in one year with no confirmed product complaint traced back to a disposition error.
- Hosted a Food and Drug Administration pre approval inspection that closed with two observations on form 483, both answered inside the fifteen day window and accepted with no further questions.
- Cut average deviation closure from 61 days to 22 by rewriting the investigation procedure and training 140 operators on root cause tools.
- Lowered repeat deviations on the filling lines by 44 percent over eighteen months using a corrective and preventive action effectiveness review program.
- Qualified nine new component and excipient suppliers and disqualified two that failed the on site audit.
- Moved 3,100 controlled documents into Veeva Vault and retired paper signature routing for batch record review.
Professional Experience
Quality Assurance Manager
Chesapeake Sterile Therapeutics, Rockville, MD 2020 to present
Leads quality assurance for a sterile injectables site with four filling lines, 380 employees and 22 commercial presentations.
- Owns batch disposition and signs release for commercial and clinical lots.
- Chairs the deviation review board and approves investigations, corrective and preventive action plans and change controls.
- Writes the annual product review for every commercial product and presents the trends to the site quality council.
- Runs supplier qualification across 64 approved vendors and leads audits of critical component makers.
- Serves as front room host for inspections by the Food and Drug Administration and by state boards of pharmacy.
Senior Quality Assurance Specialist
Potomac Pharmaceutical Services, Frederick, MD 2016 to 2020
Quality oversight of oral solid dose packaging and labeling for a contract packager serving six client companies.
- Reviewed and approved executed batch records for packaging and labeling runs.
- Investigated labeling mix ups and wrote the corrective and preventive action plans that closed them.
- Managed change control for equipment, procedures and specifications.
- Maintained quality agreements with client companies and tracked their audit commitments.
Quality Assurance Associate
Blue Ridge Clinical Supply Laboratories, Charlottesville, VA 2013 to 2016
Document control and batch record review at a small manufacturer of clinical trial materials.
- Reviewed batch records for clinical supplies and logged discrepancies for investigation.
- Maintained training records and the controlled document library.
- Supported review of environmental monitoring data from classified areas.
Licensure and Certification
Certified Quality Auditor, American Society for Quality
Member, Parenteral Drug Association
Education
Bachelor of science in microbiology, University of Maryland, College Park
Certificate in pharmaceutical quality systems, Temple University School of Pharmacy
Core Skills
Batch disposition · Aseptic process review · Deviation investigation · Corrective and preventive action · Change control · Annual product review · Supplier qualification · Inspection readiness · TrackWise · Veeva Vault · Environmental monitoring review · Quality agreements