Analytical Quality Specialist

Key Responsibilities

• Execute analytical testing of raw materials, in-process samples, finished products, and stability samples.
• Aid with method transfers, qualification studies, and validation activities for laboratory processes and systems.
• Review, verify, and document laboratory results in accordance with established quality standards.
• Support investigations related to laboratory discrepancies, out-of-specification results, and process deviations.
• Generate, review, and maintain quality records including deviations, CAPAs, change controls, and investigation reports.
• Utilize laboratory software and quality systems such as Empower, SoftMax Pro, SoloVPE, LIMS, and Trackwise.
• Participate in software qualification and validation efforts by executing test protocols and documenting outcomes.
• Ensure adherence to GMP, GDP, Data Integrity, and internal compliance requirements.
• Collaborate with Quality, Manufacturing, Validation, and Regulatory teams to support project objectives.
• Contribute to continuous improvement initiatives and provide guidance on laboratory best practices.

Required Qualifications

• Associate's degree in chemistry, Biochemistry, Microbiology, Biotechnology, Life Sciences, or a related scientific discipline.
• 35+ years of experience in a Quality Control, Analytical Laboratory, or Quality Systems role within the pharmaceutical, biotechnology, or life sciences industry.
• Experience working in a GMP-regulated environment.
• Strong understanding of laboratory investigations, analytical testing, and quality documentation practices.
• Familiarity with data review and compliance requirements related to regulated laboratories.
• Effective written and verbal communication skills.
• Ability to manage multiple priorities while maintaining attention to detail.