Senior Scientist, Quality Control jobs in United States
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Amneal Pharmaceuticals · 1 month ago

Senior Scientist, Quality Control

Amneal Pharmaceuticals is a company focused on quality control in the pharmaceutical industry, and they are seeking a Senior Scientist for their Quality Control team. The role involves performing testing of raw materials and pharmaceutical products, ensuring compliance with regulations, and participating in method transfer activities.

ManufacturingMedicalPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation. Assure compliance with state and federal regulations
Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required
Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator
Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results
Review laboratory analysis data for completeness, specification compliance, and compliance with company’s written policies
Report any abnormal findings to the Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications
Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory
Ensure that expired chemicals and reference standards are removed from laboratory area
Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor
Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels

Qualification

HPLCUV-Vis spectrophotometerChemical analysisCGMP complianceTraining skillsTeam collaborationProblem-solving

Required

Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs)
Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation
Assure compliance with state and federal regulations
Actively participate in any project work as and when assigned
Perform process validation and cleaning validation/verification testing on various drugs
Assist other scientists with analytical, instrument and software related problems as required
Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution
Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator
Document steps followed during analysis execution, calculate and report results
Actively participate in investigation of laboratory results
Review laboratory analysis data for completeness, specification compliance, and compliance with company's written policies
Report any abnormal findings to the Supervisor
As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications
Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory
Ensure that expired chemicals and reference standards are removed from laboratory area
Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor
Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels

Company

Amneal Pharmaceuticals

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Amneal Pharmaceuticals manufactures, markets and/or distributes more than 88 drugs in the United States.

H1B Sponsorship

Amneal 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 (25)
2024 (32)
2023 (33)
2022 (33)
2021 (42)
2020 (34)

Funding

Current Stage
Public Company
Total Funding
$3.2B
2023-11-16Post Ipo Debt· $2.35B
2018-05-07IPO
2017-10-01Post Ipo Equity· $854M

Leadership Team

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Chirag Patel
President & Co-Chief Executive Officer
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Company data provided by crunchbase