Senior Data Review Specialist – Chemistry (LC-MS/MS Data Review)

Position Summary: Ensure the client receives quality data in a timely manner by reviewing laboratory documentation, generated data, calculated results, and final reports for accuracy, clarity, and adherence to GMP and/or GLP regulations, and evaluating problems/system failures to achieve efficiency gains

Essential Duties and Responsibilities:

• Applies GMP/GLP in all areas of responsibility, as appropriate
• Demonstrate and promote the company vision
• Regular attendance and punctuality
• Review simple and complex routine and non-routine data (for 3 or more areas) according to departmental, corporate, and client SOPs; read and understand analytical procedures; make sure all work is performed according to GLP/GMP requirements; perform complex calculations
• Communication in writing and in person with laboratory personnel in an intelligent and clear manner
• Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process
• Perform review of scientific data, including, but not limited to standard preparation, calibrations, methodology, QC, sample data, integration review, compound evaluation, and other subjective review based on testing performed; perform complex calculations to verify results
• Verify the data is of sound quality and determine if data is compliant and defendable based on industry regulations and methodology
• May serve as technical advisor for analysts with regard to QA/QC of data
• Diagnose problems; solve simple problems, and suggest solution to complete problems in professional area
• Keep oneself and peers abreast of current developments and trends in professional area by reading and understanding internal procedures, attending/providing training sessions, by writing/revising SOPs (as required), and by assisting Group Leader / Principal Specialists in training new and existing employees
• Use MS Windows applications such as Excel, Word, Access, Outlook email; create complex Excel worksheets and formulas
• Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns
• Conducts all activities in a safe and efficient manner
• Performs other duties as assigned

Basic Minimum Qualifications (BMQ):

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.

Education/Experience (BMQ):

Master’s degree in a science-related field with at least 7-10 years of experience in Bio/Pharmaceutical Chemistry drug product/substance testing with knowledge of regulatory requirements and some data review responsibilities

Experience with analytical techniques data review such as Chromatography and Mass Spectrometry (HPLC/UPLC, LC-MS/MS, GC, GC-MS/MS, IC…etc.), knowledge of analytical method validation, USP/EP compendia, and laboratory software applications such as Waters Empower software, LIMS, Electronic Notebook is preferred. AB Sciex LC-MS/MS experience will be an added advantage.

Abilities and/or Skills:

• Honest, Dependable, Demonstrated Ability to Self-Manage
• Detail Oriented, Accurate, Precise
• Strong Math Skills
• Strong Organizational Skills
• Logical Thinking, Good Reasoning Ability
• Strong communication including verbal, writing, and presentation skills
• Dedication to quality, ethics, and customer service
• Ability to handle personal stress
• Mental and emotional stability and maturity
• Motivation to excel
• Should be able to sit for long periods as per role requirement
• Team Lead experience