QC Document Reviewer

Noven Pharmaceuticals • Miami, FL

7d

About The Position

The QC Document Reviewer is responsible for auditing all data in LIMS, Empower, laboratory worksheets, Laboratory notebooks, calibration protocols/reports and raw data archives to ensure the validity and accuracy of the data for finished product, intermedia, raw materials, components. 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.

Requirements

• 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.
• 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).

Nice To Haves

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

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees