Overview:
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.

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.

Qualifications:

• 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).

• 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