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Lupin Pharmaceuticals · 8 hours ago

Quality Assurance Data Reviewer

Coral Springs, FL

Full-time

Onsite

Senior Level

5+ years exp

Lupin Pharmaceuticals is a fast-growing company focused on innovative manufacturing and research in the pharmaceutical sector. The Quality Assurance Data Reviewer will be responsible for reviewing analytical reports and data to ensure compliance with company standards and regulatory requirements, while also supporting the QA team during audits.

BiotechnologyPharmaceuticalRobotics

H1B Sponsor Likely

Responsibilities

Ensure that analytical data generated meets company standards and regulatory requirements

Perform review of all tests results, raw data including electronic data generated in support of testing of raw materials, in-process, finished product and stability samples including, assays, chromatographic purity, content uniformity using HPLC/UPLC, particle size distribution using different techniques including Light Scattering (e.g. Malvern), density, water determination by KF, etc., and tests according to the in-house monographs and USP in a regulated laboratory environment

Check all laboratory notebooks and associated documents for correctness of raw data and verifies all reagents, standards and equipment used are within the acceptance range

Review raw data for its audit trails and instrument logs on cGMP instrumentation and equipment for laboratory data release

Review all validation and method optimization reports

Ensure chemists follow all SOPs and cGMP regulations and use the correct method or procedure for each product

Ensure notebooks are reviewed in a timely manner, in accordance with SOPs. Sign off on all analytical test results and reports

Analyze and interpret results in written and oral format

Work with analysts for document corrections and provide guidance accordingly. Guide analysts on laboratory notebook documentation requirements

Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices

Provide the required support during the regulatory and internal audits

Perform additional tasks as assigned by QA supervisor

Qualification

HPLC/UPLCPharmaceutical analysisCGMP regulationsAnalytical instrumentationSOPs understandingTeam collaborationWritten communicationOral communication

Required

Bachelor's degree in Chemistry or related field

5+ years related experience in pharmaceutical analysis and QA data review

Previous experience using all types of analytical instrumentation, software, and tests performed in the lab, including: Familiarity with testing and lab practices associated with HPLC/UPLC, GC, FT-IR, Empower, etc. is required

Understanding of SOPs, ICH, USP/NF procedures and requirements

Preferred

Previous cGMP/regulatory experience is preferred

Company

Lupin Pharmaceuticals

Lupin Pharmaceuticals is a generic pharmaceutical company.

Founded in 2003

Baltimore, Maryland, USA

501-1000 employees

http://www.lupinpharmaceuticals.com

H1B Sponsorship

Lupin Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (3)

2024 (6)

2023 (2)

2022 (8)

2021 (6)

2020 (4)