Senior Quality Analyst(Raman Spectroscopy) from Joulé
Exton, PA
About the Job
Job Title:Biologics Quality Analyst
Location: Exton, PA
Type: Contract
Overview
Join a pharmaceutical company operating globally in terms of R&D, manufacturing and marketing, with a strong focus on prescription medicines.
Responsibilities
Requirements
Education and Experience
Technical
Benefits
System One offers 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.
#M3
Location: Exton, PA
Type: Contract
Overview
Join a pharmaceutical company operating globally in terms of R&D, manufacturing and marketing, with a strong focus on prescription medicines.
Responsibilities
- 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.
Requirements
Education and Experience
- 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.
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.
Benefits
System One offers 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.
#M3