Overview

Compliance Team, LLC. is a leading provider of technical consulting services to our clients in the pharmaceutical, biotechnology, and medical device industries in the areas of commissioning, qualification, validation and regulatory compliance.  We are proud of our talented professionals and the major contributions they make to our clients’ successes on mission critical projects. 

 Become part of our team! We an exciting opportunity for for a Test Method Validation Engineer.  We seek a top-notch professionals with HPLC and LC/MS experience to provide test method development and validation in a medical device laboratory environment.

Responsibilities

This role will require a self-starting laboratory scientist to perform method validation for analytical methods using HPLC and LC/MS methods in one of our laboratories in the St. Louis area.

The individual shouls have experience in a regulated laboratory in an FDA-regulated pharmaceutical or medical device setting, performing pre-validation studies to determine sensitivity, specificity linearity, limit of detection, limit of quantiation, and technician/operator/instrument equivalanciy studies, as well as evaluating instrument IQ/OQs, authoring engineering study reports, executing test method validation protocols and performing test method validations, 

Qualifications

The following listed requirements need to be met at a minimum:

• Bachelor degree in Chemistry, or related field 
• Fluent in English
• 3+ years' experience in of performing test method validations in the Chemistry laboratory
• Knowledge of FDA regulations and pharmaceutical GMPs
• Excellent self-management, time management, and problem-solving skills, with ability to prioritize activities effectively.
• Ability to function in multidisciplinary teams, possessing excellent documentation, presentation, training, and computer skills
• Familiar with pharmaceutical manufacturing process, facilities and equipment, calibration, IQ, OQ, and analaytical method validation, and development of SOPs
• Must be willing to work at the project site 

In addition to the above technical competencies, ideal candidates will have a commitment to deliver quality service with outstanding interpersonal, oral, and written communication skills. Candidates must be results-oriented, able to make decisions, and able to prioritize work per business needs. Strong communication, organization, and time management skills are necessary. Desired skills include: teamwork, leadership, ability to maintain constructive relationships with personnel from various disciplines at all levels in the organization. The successful candidate should demonstrate integrity, reliability, dedication, adaptability, innovation, and self-motivation.