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.
• 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.

• 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.
• 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).

Judgment / Decision Making:

Duties are performed under general direction toward broad assignments with periodic reviews. Duties are performed within the framework of departmental or functional guidelines, requiring interpretation and original thinking.

Work Environment:

An office environment but on occasions could be work in a laboratory environment with exposure to chemicals, caustics, fumes, heat, and electrical current.

Physical Demands:         

Visual acuity and manual dexterity required to operate computer, analytical instrumentation, sample preparation and proofread documents. The majority of time spent sitting and walking. Often required to lift objects weighing up to 20 pounds.