Senior Quality Assurance Specialist

3 weeks ago

Exton, Pennsylvania, United States Zenith LifeScience Full time

We are seeking a highly skilled Raw Material Expert with extensive knowledge and hands-on experience in Raman spectroscopy to join our team at Zenith LifeScience.

The successful candidate will be responsible for the analysis and characterization of raw materials, ensuring their quality and suitability for production processes.

This role involves working closely with cross-functional teams to develop and implement testing protocols, troubleshoot material issues, and support continuous improvement initiatives.

Key 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 Skills:

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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