Quality Analyst - Senior

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Job description

QUALITY ANALYST

EXTON, PA

100% on-site

12+ Month Contract

Raw Material Expert with extensive knowledge and hands-on experience in Raman spectroscopy. Responsible for the analysis and characterization of raw materials, ensuring their quality and suitability for production processes. Work closely with cross-functional teams to develop and implement testing protocols, troubleshoot material issues, and support continuous improvement initiatives.

REQUIRED:

• Bachelor's or Master's degree in Chemistry, Material Science, or a related field.

• Proven experience in using Raman spectroscopy for material analysis.

• Strong understanding of material properties and their impact on production processes.

• Excellent problem-solving skills and attention to detail.

• Ability to work effectively in a team-oriented environment.

• Training within a regulated Pharmaceutical/biotech/medical device environment.

• Understanding and application of cGMP's (EP, JP, USP).

• Detailed knowledge and application with electronic Quality Systems and Data Integrity.

Essential Functions

• Conduct detailed analysis of raw materials using Raman spectroscopy and other analytical techniques.

• Develop and validate testing methods to ensure the accuracy and reliability of material characterization.

• Collaborate with R&D, quality assurance, and production teams to address material-related challenges.

• Maintain accurate records of all analyses and prepare comprehensive reports.

• Stay updated with the latest advancements in Raman spectroscopy and material science.

Technical:

• Strong attention to detail as demonstrated through consistent quality of work.

• Excellent written and verbal communication skills.

• Computer proficiency in MS Word and Excel, MS Access required.

• Demonstrates process orientation-thinks through required steps and sequencing to ensure quality work output.

• Ability to anticipate potential problems and take proactive action to avoid/minimize impact. Function as change agent to ensure accurate and timely facilitation of global and department, GMP, etc. changes.

• Anticipates consequences of actions and how they impact other areas.

• Ability to utilize project management skills to independently prioritize, plan and schedule workflow.

• Timely follow up to ensure satisfactory resolution to issues.

• Knowledge of CGMPs (relevant laws, guidance, directives, and industry practice), and demonstrated ability to apply learnings appropriately in a controlled environment.

• Ability to interpret and apply GMPs, relevant laws, guidance's, and directives to extremely complex pharmaceutical situations.

• Ability to work and coordinate activities across multiple functional groups with a sense of professionalism and urgency.

• Ability to work collaboratively with internal and external team members and customers/contacts.

• Self-motivated; able to work with minimal supervision. Exercises independent judgment in evaluating compliance.

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