Dominique R. Overby
Manufacturing Pharmacist, Solid oral dose manufacturing
Kansas City, MO · (858) 555 0171 · name@example.com · linkedin.com/in/dominiqueroverby
Key Qualifications
EXPERIENCE
Eight years in pharmaceutical manufacturing after two years in retail pharmacy
INDUSTRIES
Solid oral dose manufacturing, retail pharmacy
SPECIALTIES
Batch record review, deviation investigation, in process control, operator training
SYSTEMS
TrackWise, laboratory information management system, Veeva Vault, SAP
CREDENTIALS
Licensed pharmacist, Missouri Board of Pharmacy
EDUCATION
Doctor of Pharmacy, University of Missouri Kansas City
Results at a Glance
640
Batch records
74
Deviations inside
60%
Operator retraining program
45%
Redesigning three record
Executive Summary
Licensed pharmacist on the production floor of a solid dose plant, reviewing batch records, closing deviations and signing product to the next step. Works to current good manufacturing practice requirements under parts 210 and 211 and knows which questions to ask before a batch is released.
Signature Achievements
- Reviewed 640 batch records in a year with a first pass acceptance rate of 96 percent at quality release.
- Closed 74 deviations inside the 30 day target and wrote the corrective and preventive action plans behind them.
- Cut repeat weight variation deviations on two compression lines by 60 percent through an operator retraining program.
- Supported a Food and Drug Administration preapproval inspection as the floor subject matter expert on batch documentation.
- Reduced batch record documentation errors by 45 percent after redesigning three record sections with operators.
- Qualified 18 operators on granulation and compression steps with all qualification records complete.
Professional Experience
Manufacturing Pharmacist
Blue River Solid Dose, Kansas City, MO 2020 to present
Floor pharmacist on a tablet and capsule site running 40 commercial products across two shifts.
- Reviews executed batch records for completeness and compendial compliance before quality release.
- Investigates deviations on the floor, writes the report and drives the corrective and preventive action in TrackWise.
- Verifies in process control results against specification and holds product when a result falls outside limits.
- Trains and qualifies operators on procedures and good documentation practice.
- Supports process validation runs by checking sampling plans and documenting execution.
Staff Pharmacist
Westport Neighborhood Pharmacy, Kansas City, MO 2018 to 2020
Dispensing pharmacist at an independent pharmacy filling 180 prescriptions a day.
- Verified prescriptions and counseled patients on new medications.
- Managed controlled substance records and inventory counts.
- Compounded simple preparations to United States Pharmacopeia standards.
Licensure and Certification
Licensed pharmacist, Missouri Board of Pharmacy, license 2018 044117
Member, International Society for Pharmaceutical Engineering
Education
Doctor of Pharmacy, University of Missouri Kansas City, 2018
Core Skills
Batch record review · Deviation investigation · Corrective and preventive action · In process controls · Process validation support · TrackWise · Operator qualification · Good documentation practice · Compendial standards · Change control