Senior Quality Analyst

1 week ago

Exton, Pennsylvania, United States Joulé Full time
Job Title: Biologics Quality Analyst

Location: Exton, PA

Type: Contract


Overview

At Joulé, we are seeking a highly skilled Biologics Quality Analyst to join our team. As a key member of our quality assurance team, you will be responsible for conducting detailed analysis of raw materials using Raman spectroscopy and other analytical techniques.


Responsibilities
  1. Conduct detailed analysis of raw materials using Raman spectroscopy and other analytical techniques.
  2. Develop and validate testing methods to ensure the accuracy and reliability of material characterization.
  3. Collaborate with R&D, quality assurance, and production teams to address material-related challenges.
  4. Maintain accurate records of all analyses and prepare comprehensive reports.
  5. Stay updated with the latest advancements in Raman spectroscopy and material science.


Requirements
  1. Bachelor's or Master's degree in Chemistry, Material Science, or a related field.
  2. Proven experience in using Raman spectroscopy for material analysis.
  3. Strong understanding of material properties and their impact on production processes.
  4. Excellent problem-solving skills and attention to detail.
  5. Ability to work effectively in a team-oriented environment.
  6. Training within a regulated Pharmaceutical/biotech/medical device environment.
  7. Understanding and application of cGMP's (EP, JP, USP).
  8. Detailed knowledge and application with electronic Quality Systems and Data Integrity.


Technical Skills
  1. Strong attention to detail as demonstrated through consistent quality of work.
  2. Excellent written and verbal communication skills.
  3. Computer proficiency in MS Word and Excel, MS Access required.
  4. Demonstrates process orientation—thinks through required steps and sequencing to ensure quality work output.
  5. Ability to anticipate potential problems and take proactive action to avoid/minimize impact.
  6. Function as change agent to ensure accurate and timely facilitation of global and department, GMP, etc. changes.
  7. Anticipates consequences of actions and how they impact other areas.
  8. Ability to utilize project management skills to independently prioritize, plan and schedule workflow.
  9. Timely follow up to ensure satisfactory resolution to issues.
  10. Knowledge of CGMPs (relevant laws, guidance, directives, and industry practice), and demonstrated ability to apply learnings appropriately in a controlled environment.
  11. Ability to interpret and apply GMPs, relevant laws, guidance's, and directives to extremely complex pharmaceutical situations.
  12. Ability to work and coordinate activities across multiple functional groups with a sense of professionalism and urgency.
  13. Ability to work collaboratively with internal and external team members and customers/contacts.
  14. Self-motivated; able to work with minimal supervision. Exercises independent judgment in evaluating compliance.


Benefits

At Joulé, we offer eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

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