Quality Control Reviewer-GLP

This position is responsible for performing activities to support the quality control of bioanalytical programs conducted in the bioanalytical laboratories to ensure compliance with GDP and GLP regulations and guidance. This individual will also ensure accurate documentation, timely completion of all analytical related testing, and timely review of data, while adhering to standard operating procedures.

Responsibilities and Job Duties

• Conducts data review of analytical test results from PK, ADA and NAb assays including assay method paperwork for Good Document Practices (GDP), completeness and accuracy.
• Performs 100% verification of all raw data transfers, data analysis and verification of reported results
• Identifies appropriate resolution of GDP and calculation errors and determine what errors require deviations to methods, SOPs, or study protocols or sample analysis plans. Making recommendations to prevent reoccurrences
• Performs data table and data analysis review for PK, ADA and Nab method validations to ensure no errors were made during the transcribing process. Brings errors/concerns to manager for review and resolution.

• Conducts QC review of bioanalytical reports including 100% verification of data in report tables, 100% verification of all numbers/values in written sections of reports. Verifies referencing text against cited source documentation and consistency of reference citation style and that all figures are generated using the correct data.
• Performs QC review of reagent preparation, reagent logbooks and equipment calibration and maintenance records to ensure accuracy.
• Performs QC review of assay, reagent, sample forms and other laboratory forms, both paper- and electronic-based to ensure accuracy.
• Assists with bioanalytical report generation to identify any inaccuracies. Works with lab personnel to resolve any discrepancies.
• Assists in the creation of bioanalytical lab and job-related SOPs. Perform QC review of bioanalytical laboratory SOPs for consistency and clarity. Communicates any discrepancies manager and documents for potential corrective action.
• Assist with laboratory investigations, discrepancies and CAPAs.
• Assist the BA Lab Project Manager with assigned tasks.

Minimum Qualifications

Education & Experience

• Bachelor's degree in Biology or Biochemistry or similar scientific field of study with a demonstrated knowledge of bioanalytical methods and laboratory procedures
• Three years of related experience
• At least 2 years' experience in an FDA regulated environment

Knowledge, Skills and Abilities

• Ability to comprehend assay methodology, calculations and expected documentation practices.
• Detail oriented with the ability to prioritize work from multiple programs.
• Ability to work in the laboratory 20% of the time verifying records related to sample, reagent and equipment
• Ability to work at a computer 80% of the time in sitting position.

Supervisory Responsibilities

None

Preferred Qualifications

• Previous experience in a data review function
• Previous experience performing immunoanalytical/ligand-binding assays or working in a pharmaceutical and/or laboratory environment
• Familiar with LIMS and EL.
• Familiarity with FDA GLP (21CFR Part 58) regulation.

Additional Information

The annual rate of pay for this position ranges from $80,300 - $122,500. For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company's discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company's benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits.

The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.