Chemistry Data Analysis/Lab Operations

Job Description

Employee Responsibilities:

The independent auditing of laboratory data to ensure that regulatory compliance is maintained

Maintain the highest level of proficiency in terms of those duties and responsibilities required of auditors

Foster a customer service attitude within and among laboratory personnel

Ensure the laboratory data is in compliance with cGMPS, GLPs, and departmental procedures and assay methods and is of the highest integrity, quality and accuracy

Review laboratory notebooks, logbooks, and CTU records to ensure compliance to data integrity and accuracy

Complete the remediation activities of all data reviews to ensure errors are appropriately corrected and documented following departmental and site procedures

Data review will include the evaluation of raw data as well as verification of final data integrity (i.e., calculations, adherence to SOPs, BATs, BLPs, Compendia, etc

Works with laboratory staff and management to remediate comments and errors in documentation

May assist in conducting investigations associated with laboratory data review

Minimum 1-2 Years' experience in Quality, Regulatory, or related experience

General laboratory skills and background knowledge

Experience using Microsoft Office programs such as Word and Excel

Strong computer, scientific, and organizational skills

Excellent communication (oral and written) and attention to detail

Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude

Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies