Laboratory Compliance Specialist

Description:

About the Role

Are you passionate about materials science and analytical chemistry? As a Laboratory Compliance Specialist, you will play a critical role in supporting our internal materials characterization laboratory by ensuring the integrity and compliance of data, documentation, and testing interpretations. While this is not a hands-on laboratory position, it requires strong scientific judgment to partner with R&D engineers and scientists, enabling high-quality analytical and materials science testing. This role is essential in maintaining regulatory compliance and driving continuous improvement in documentation and laboratory practices.

Key Responsibilities

• Conduct peer reviews of analytical test data and materials characterization results using both paper-based and electronic systems with minimal supervision.

• Validate data intended for regulatory submissions to ensure accuracy and compliance.

• Recommend and implement process improvements to enhance laboratory efficiency and regulatory adherence.

• Lead initiatives to strengthen documentation practices and standards.

• Initiate or facilitate laboratory investigations (OOS/OOT, deviations, non-conformances) based on review findings.

• Author and revise methods, procedures, and work instructions; contribute to protocols, reports, SOPs, and technical documentation.

• Provide compliance oversight and support for special projects within or beyond the characterization lab.

• Review secondary documentation such as equipment logs, verification logs, and training records.

• Collect, analyze, and trend quality indicator data to support laboratory objectives and management reviews.

• Assist with transitions to new laboratory systems as required.

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Required Qualifications

• Bachelor's degree in chemistry, materials science/engineering, biology, biochemistry, or a related field-or equivalent relevant experience.

• Minimum of 3 years of experience in a laboratory scientist/engineer role or in peer/quality review or technical writing.

• Strong knowledge of good documentation practices and familiarity with ISO standards and/or quality systems.

• Proven experience in a regulated, audit-facing environment.

• Proficiency in Microsoft Office Suite (Word, Excel, Teams, Outlook).

Preferred Qualifications

• Hands-on experience interpreting materials science testing results, including metallography, microhardness testing, SEM/EDS, tensile testing, corrosion testing, and chemical analysis.

• Familiarity with PTFE material testing and characterization.

• Exceptional technical writing and communication skills.

• Proficiency in software tools such as Trios, Minitab, Empower, and OMNIC/OMNIC Paradigm.

• Knowledge of sample preparation and various mechanical and analytical testing methods.

• Ability to provide constructive feedback on documentation.