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Noven Pharmaceuticals · 2 months ago

QC Analyst II

US-FL-Miami

Full-time

Onsite

Mid, Senior Level

4+ years exp

Noven Pharmaceuticals is a company focused on quality control in the pharmaceutical industry. The QC Analyst II role involves performing testing on raw materials and pharmaceutical products, ensuring compliance with established procedures and protocols, and providing technical support within the laboratory.

BiotechnologyHealth Care

H1B Sponsor Likely

Responsibilities

Performs professional, technical laboratory functions with versatile capabilities throughout the laboratory

Serves as a technical resource in the laboratory providing scientific expertise and problem-solving skills

The Analytical QC Analyst II is an integral part of the team, contributing to our success by performing raw materials and commercial pharmaceutical products testing according to compendial methods and/or internal standards test procedures (STPs)

Conducts Analytical testing of Raw Materials, Intermediate Products and Finished products as per written procedures and protocols to support material/product release, stability studies, method transfers, method verifications and investigations

Troubleshoot, operate, and train for testing associated with general analytical instruments for testing of raw material, in process and finished products using instruments such as HPLC, GC, Dissolution, UV, IR, automatic titrator, and viscometer

Ensures testing is properly conducted and documented for all performed activities with emphasis on data integrity

Prepare test solutions, volumetric solutions, and samples used in analysis

Performs assigned physical tests, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished, components, and stability products in an FDA regulated lab environment

Notifies supervisor immediately regarding testing abnormalities, OOS/OOT results, and deviations from established testing procedures. Serves as a lead investigator in conducting and documenting the investigation

Functions as a subject matter expert within the analytical laboratory and always provides support

Performs training and provides technical support to junior analysts as required

Works under minimal supervision and is expected to independently carry-out non-routine assignments

Actively completes assigned training activities and documents training within assigned time frames and before performing any activity associated with the training topic

Maintains proper documentation of laboratory data (which requires adequate proficiency in written and computational skills)

Reviews analytical testing records/logbooks for compliance with cGMPs, compendial requirements, and Noven procedures/protocols

Reviews and/or writes technical reports, procedures, and protocols

Draws conclusions from data and communicates those conclusions is writing

May Schedule laboratory testing and associated activities to minimize operational disruptions to departments

May manage inter-departmental projects to ensure timely completion of objectives

Completes any other duties assigned by QC management as required

Qualification

HPLCGCChromatographic analysisCompendial testingAnalytical methodsScientific softwareMicrosoft applicationsWritten communicationVerbal communicationInterpersonal skillsLeadership skillsOrganizational skills

Required

Minimum of four years of experience with a bachelor's degree in chemistry or related scientific field required

Alternately, three to six years of experience with a master's degree in chemistry or related scientific field

Alternately, zero to three years of experience with a PhD in chemistry or related scientific field -Required

Broad knowledge of scientific principles, methods, chromatographic analysis, analytical methods (i.e. HPLC, GC, Dissolution) and a good understanding of separation theories -Required

Candidate must have broad knowledge in all types of compendia testing (USP, EP, JP, BP) and wet chemistry techniques-Required

Good written English and verbal communication skills-Required

Must be highly organized and able to work under pressure

Must have strong interpersonal and leadership skills

Must be computer literate with knowledge in all Microsoft business applications

Preferred

Strong background in scientific software such as Waters Corp. Empower and LIMS is a plus

Company

Noven Pharmaceuticals

Noven Pharmaceuticals, Inc.

Founded in 1987

Miami, Florida, USA

201-500 employees

http://www.noven.com

H1B Sponsorship

Noven 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

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Trends of Total Sponsorships

2025 (1)