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Noven Pharmaceuticals · 4 weeks ago

QC Document Reviewer

Miami, FL

Full-time

Onsite

Mid Level

4+ years exp

Noven Pharmaceuticals is seeking a QC Document Reviewer responsible for auditing data in various laboratory systems to ensure the validity and accuracy of data for finished products and raw materials. The role involves detailed data review, compliance with GLP and internal SOPs, and collaboration with analysts and internal departments.

BiotechnologyHealth Care

H1B Sponsor Likely

Hiring Manager

Marilyn Reynaldo

Responsibilities

This individual will be responsible for carrying out sample analysis and data processing within stated timeframes and in accordance with Standard Operation Procedures (SOPs) and Company Policies

Perform detailed data review of test results from HPLC, GC, IC assays for compliance with GLP and internal SOPs to support laboratory operation

Review lab equipment calibration records, logbooks, and other review functions as needed

Compile and maintain review records in accordance with SOP's and QC best practices

Work with analysts to complete any corrections to data notebooks, LIMS, Empower, etc

Communicate and respond to inquiries from internal departments regarding the status of results

Prepare and review forms and SOPs as needed

May be required to assist in training personnel in review procedures

Assist in preparing internal departmental documents such as SOPs, training documents, methods, and study plans

Must always comply with the Laboratory Safety Policy

Qualification

HPLCGCLIMSEmpowerGLPCompendia testingAnalytical methodsMicrosoft 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

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

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

Good written English and verbal communication skills

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

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

Knowledge of GLP

Ability to multi-task and participate in multiple studies concurrently

Ability to produce high quality data while working under the pressure of strict deadlines

Work may require the use of PPE (personal protective equipment)

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

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)