Senior Data Review Specialist – Chemistry

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 :

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 (HPLC/UPLC GC ICetc.) knowledge of analytical method validation USP/EP compendia and laboratory software applications such as Waters Empower software LIMS Electronic Notebook is preferred.

Additional Information :

Key Candidate Attributes:

• Self-motivation; excellent quality of work and attention to detail
• Ability to communicate effectively with coworkers and internal/external clients
• Ability to learn new tasks quickly and to move easily from task to task
• Ability to handle prioritization and multiple tasks simultaneously
• Ability to use a personal computer and learn necessary programs
• Good communication skills (oral and written)
• Organizational ability and good judgement
• Science background/education and/or laboratory experience
• Strong Math Skills
• Logical Thinking Good Reasoning Ability
• Motivation to excel
• Coaching/mentoring of peers

Remote Work :

No

Employment Type :

Full-time