Randip Kaur

Experienced Quality Control Laboratory Manager and Chemist with a focus on product quality and regulatory compliance in laboratory operations. Specializes in analytical testing, method validation, and data integrity. Delivers optimized laboratory workflows and implements quality systems while ensuring GMP adherence. Proficient in authoring technical documentation and streamlining processes to enhance audit readiness and regulatory compliance.

Quality Control Manager - Certified Laboratories - Tustin, California

(2022-07 - 2026-03)

Managed Microbiology, Biochemistry, Wet Chemistry, HPTLC, and GC/GC-MS laboratories, overseeing daily operations and ensuring compliance with quality and regulatory standards.

• Reviewed and approved analytical data, ensuring accuracy, integrity, and compliance with SOPs and GMP requirements.
• Led authoring and review of Out-of-Specification (OOS) and deviation investigations, including root cause analysis and implementation of corrective and preventive actions (CAPA).
• Coordinated daily testing schedules to align with project timelines and ensure timely release of laboratory reports.
• Served as a technical point of contact for clients, addressing analytical data and method-related inquiries.
• Supported Quality Assurance during internal and ISO audits, ensuring audit readiness and timely resolution of findings.
• Trained, interviewed, and onboarded new laboratory personnel, strengthening team capability and performance.
• Troubleshot laboratory, testing, and instrumentation issues, minimizing downtime and improving efficiency.
• Provided regular updates on laboratory performance and metrics to senior management, facilitating informed strategic decision-making.

Chemistry Technical Specialist - Certified Laboratories - Tustin, California

(2022-05 - 2022-07)

Media Manufacturing Quality Control Manager - Phenomenex, Inc. - Torrance, California

(2021-12 - 2022-04)

Managed quality control testing for media manufacturing, ensuring timely release of silica and media to support production schedules.

• Reviewed non-conformance reports (NCRs) and out-of-specification (OOS) results, verifying effectiveness of corrective and preventive actions (CAPA) to ensure compliance.
• Collaborated with R&D and cross-functional teams to investigate root causes of NCRs and OOS events, enhancing quality assurance processes.
• Assisted Quality Assurance with internal and ISO audits.
• Conducted Gemba walks to monitor laboratory operations and identify opportunities for continuous improvement, fostering a culture of quality.

Quality Control Supervisor - Kova International, Inc. - Garden Grove, California

(2020-04 - 2021-12)

• Test finished product and bulk samples of clinical urinalysis controls.
• Test raw materials used in manufacturing of clinical urinalysis controls.
• Trained new analysts, filed complaints, wrote non-conformance and deviation reports, and reviewed QC paperwork, batch records, and manufacturing documentation.
• Scheduled daily QC tasks and developed new SOPs and lab protocols to enhance operational consistency.
• Maintain all QC urine analyzers.
• Review clinical urinalysis controls labels and final control kits prior to shipping.
• Conducted research and development projects to innovate and improve clinical urinalysis controls.
• Assist with MDSAP audit and internal audits.

Regulatory Affairs Manager - Med Pharmex Inc. - Pomona, California

(2018-08 - 2020-02)

• Prepared and submitted regulatory filings, including Annual Drug Experience Reports, Minor Stability Changes Reports, JINAD submissions, CBE-0, CBE-30, and PAS.
• Coordinated Adverse Event reporting and product recall submissions to FDA, ensuring compliance with regulatory requirements.
• Supported FDA inspections, customer audits, and authored responses to Form 483 observations.
• Updated and maintained Veterinary Master Files (VMF) to ensure current and accurate regulatory documentation.
• Authored and revised SOPs, process validation protocols, and pilot batch records.
• Authored OOS and deviation reports for quality control laboratory data.
• Conducted OOT stability investigations.
• Reviewed batch records for accuracy and compliance with GMP standards, supporting quality assurance initiatives.

Regulatory Affairs Specialist - Med Pharmex Inc. - Pomona, California

(2016-07 - 2018-08)

Associate Supervisor QC Chemistry - Med Pharmex Inc. - Pomona, California

(2015-02 - 2016-07)

QC Lead Chemist - Med Pharmex Inc. - Pomona, California

(2005-06 - 2015-02)

Ensure quality and purity of raw materials, finished products and stability for leading distributor of high quality generic veterinary medicines.

• Test finished products and stability samples using USP and in-house methods and perform USP and manufacturer's impurities testing on raw materials.
• Test verification of compendial methods.
• Test manufacturer's raw material impurities methods.
• Operate and troubleshoot HPLC /UPLC.
• Developed and documented new lab test procedures and standard operating procedures to ensure compliance and consistency.
• Collaborated on special projects that streamlined lab processes and improved overall efficiency.
• Trained new chemists on lab equipment and procedures, facilitating their onboarding and integration into the team.

QC Chemist II - International Medications Systems, Ltd. - South El Monte, California

(2004-08 - 2005-06)

QC Chemist I - International Medications Systems, Ltd. - South El Monte, California

(2003-01 - 2004-08)

Tested raw materials, finished products, and stability samples of sterile, injectable pharmaceuticals to ensure quality and compliance with industry standards.

• Conducted testing of Water for Injection for total organic carbon and heavy metals to verify safety and purity.
• Conducted tests on raw materials to determine melting points and identify substances.
• Performed titrations, standardized volumetric solutions, and additional testing to ensure compliance.
• Prepared Certificates of Analysis for raw materials and finished pharmaceutical products to document compliance with regulatory requirements.
• Ensure regulatory compliance by learning USP, BP, EP and JP Methods.

Chemist I - Watson Labs - Corona, California

(2002-08 - 2002-12)

• Prepared assay, content uniformity, and chromatographic purity samples of tablets to ensure compliance with USP and FDA regulations.
• Studied and adhered to Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) in the laboratory environment.
• Operated HPLC and UV-VIS spectrometers for accurate analysis of chemical compounds.

Bachelor of Science - Chemistry - University of California Riverside