Konika Gandhi

Quality Control Biochemist I at Granules Pharmaceuticals Inc. (2022-12 – 2026-07)

Operated and maintained advanced laboratory instruments including HPLC, UPLC, UV-Vis, dissolution apparatus, Karl Fischer (KF), and Malvern Mastersizer.
Conducted analytical testing (Assay, Dissolution, content uniformity, blend uniformity, particle size distribution, density, viscosity, and water determination) for product development samples.
Performed multimedia dissolution and dose-dumping studies to support ANDA submissions.
Executed calibrations, qualifications, preventive maintenance, and routine troubleshooting for HPLC, dissolution systems, KF titrators, and FT-IR instruments.
Documented experimental data accurately, ensuring strict compliance with internal SOPs, cGMP, and FDA regulations.
Prepared, reviewed, and approved analytical data, technical reports, and analytical methods
Investigated Out-of-Specification (OOS) and Out-of-Trend (OOT) results, supporting all levels of laboratory deviation and failure investigations.
Managed laboratory inventory (chemicals, columns, standards, and consumables) to ensure uninterrupted testing schedules.

Quality Control DEA Coordinator & Technical Writer at Granules Pharmaceuticals Inc. (2022-05 – 2022-12)

Served as an authorized personnel for the DEA Vault within the Quality Control laboratory.
Compiled, analyzed, and prepared stability summary reports and test data for stability samples to ensure compliance with cGMP protocols.
Managed controlled substances inventory using LIMS software, overseeing the receipt, logging, issuance, and disposal of released samples and reference standards.
Assisted the stability coordinator with daily monitoring, walk-throughs of stability chambers, and the preparation/revision of stability summary reports.
Participated in cross-functional data compilation for multiple reduced-testing projects submitted for FDA review and approval.
Initiated and managed change controls for the revision and optimization of various Standard Testing Methods (STMs) and Standard Operating Procedures (SOPs).
Executed daily QC laboratory operations in strict compliance with cGMP, internal SOPs, and regulatory agency guidelines.

Pharmacy Technician at Walgreens (2021-01 – 2022-12)

Assisted pharmacists with workflow scheduling, inventory management (ordering, unpacking, and storing pharmaceuticals), and third-party prescription insurance claims.
Administered COVID-19 tests and communicated results to patients under pharmacist supervision.
Handled physician and patient telephone inquiries, resolved customer service issues, and managed cash register transactions.

Pharmacy Assistant at Unichem Pharmacy (2018-03 – 2020-10)

Processed prescriptions and entered patient data into the pharmacy database under pharmacist supervision.
Advised customers on basic medication directions, routes of administration, and potential drug interactions.
Managed front-of-store operations, including inventory tracking, restocking OTC medications, receiving deliveries, and cash flow reconciliation.

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