Quality Control/Quality Assurance Resume

SUMMARY

PROFESSIONAL EXPERIENCE

Quality Control/Quality Assurance

Confidential

Responsibilities:

QA Inspection, reporting, approval/release, record keeping for raw materials, in process and finished goods testing
Detailed administrative record keeping and filing of all QA activities as required, including generation of CofA’s and data entry into the Laboratory Information Management System (LIMS)
Determine and calculate batch adjustments as necessary, mathematical and bench blends
Prepare and standardize reagents, maintain stock of supplies and chemicals, write up requisitions
Maintain lab instruments, equipment and apparatus in good condition. Calibrate as directed and keep records

Confidential

Responsibilities:

Perform AX, RP, SE, and SX HPLC purification on incoming compounds, final products, and in process QC samples
Produce research and clinical grade components and products within ISO 5 and greater environments
Purify catalog and custom compounds per SOP or client specifications
Run reactions, work up products, and submit samples for analytics
Participate in the set - up, cleaning, operation, and maintenance of laboratory equipment
Perform chemical and enzymatic reactions following aseptic procedures
Prepare for production by reviewing production schedule; studying and clarifying expectations; calculating requirements; assembling materials and supplies
Provides written and verbal updates to supervisors or other department managers
Ensures timely completion and compliance with cGMP and all other relevant company training requirements
Prepares production areas for cGMP project initiation or changeover
Write and execute batch records, author and review SOP’s, and maintain quality documents associated with manufacturing
Participate in the maintenance and overall cleanliness of the workspace
Keep equipment operating by following operating instructions and troubleshooting breakdowns