Senior Data Review Specialist – Chemistry (LC-MSMS 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

Qualifications :

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):

Masters 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 ICetc.) 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.

Additional Information :

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

Remote Work :

No

Employment Type :

Full-time