Johria Shaukat

Performed visual and analytical inspection of sterile IVs in a 503B pharmaceutical manufacturing facility. Conducted analytical tests onfinished products using HPLC, UPLC, and ICP-MS.

Followed Standard Operating

Procedures (SOPs), Work Instructions (WIs), cGMP, and cGLP requirements for all laboratory testing.

Quality Control Chemist - CAPS Pharmacy - Allentown, PA

(2025-03 - 2025-08)

• Performed visual and analytical inspection of sterile IVs in a 503B pharmaceutical manufacturing facility.
• Conducted analytical tests onfinished products using HPLC, UPLC, and ICP-MS.
• Followed Standard Operating Procedures (SOPs), Work Instructions (WIs), cGMP, and cGLP requirements for all laboratory testing.
• Recorded analytical results and maintained accurate documentation using LIMS.
• Supported failure investigations and collaborated with cross-functional teams to resolve quality issues.
• Coordinated with Manufacturing and Quality teams to ensure timely batch review and product release.
• Maintained laboratory inventory, stocked supplies, and ensured a clean, organized GMP-compliant work environment.

Formulations Chemist - OraSure Technologies - Bethlehem, PA

(2022-01 - 2024-11)

• Prepared chemical formulations according to Batch Production Records (BPRs), SOPs, and Work Instructions.
• Participated in manufacturing and engineering studies, validation protocols, and process improvement initiatives.
• Performed testing and evaluation of raw materials, reagents, and in-process materials to ensure compliance with quality specifications.
• Entered laboratory and material data into SAP while maintaining documentation readiness for internal and regulatory audits.
• Assisted in training new laboratory personnel on laboratory procedures, GMP practices, and safety protocols.
• Operated HPLC, mass spectrometry, and other analytical laboratory instruments.
• Maintained laboratory inventory and ensured adequate supplies for daily operations.
• Collaborated with cross-functional teams to optimize laboratory efficiency and resolve manufacturing issues.

Quality Analyst - AmeriSci New York - New York, NY

(2019-04 - 2021-09)

• Performed quality testing on customer samples and prepared analytical reports.
• Supported FDA inspections and internal quality audits.
• Reviewed documentation to ensure compliance with FDA and GMP regulations.
• Conducted inspections of labels, and finished products before release.
• Identified product nonconformances and participated in root cause and failure investigations.
• Assisted with corrective actions and continuous improvement initiatives.
• Participated in training programs to learn new laboratory procedures and quality systems.

Bachelor's degree - Biology/chemistry - CITY College (2016-08 - 2018-06)