Sr Data Review Specialist – Pharmaceutical Microbiology

Position Summary:

• Ensuring that the client receives quality data by reviewing laboratory data for accuracy clarity and adherence to GMP and/or GLP regulations

Essential Duties and Responsibilities: 

• Applies GMP/GLP in all areas of responsibility as appropriate
• Demonstrate and promote the company vision
• Regular attendance and punctuality
• Read and understand analytical procedures
• Review documentation generated data calculated results and final reports according to departmental corporate and client SOPs
• Gain a technical understanding of the techniques in which review is being performed
• Use MS Windows applications such as EXCEL Word Access Outlook email
• 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 Microbiology field with 4-7 years of experience in Bio/Pharmaceutical drug product/substance testing with knowledge of regulatory requirements.

Theoretical / Practical experience with analytical techniques such as environmental monitoring water testing Gel clot endotoxins growth promotion kinetic endotoxin MLT organism identification Disinfectant efficacy study Microbial limit validations and particulate matter testing. Knowledge of USP/EP compendia and LIMS Electronic Notebook is preferred.

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