Scientist, Quality Control - QC Analysts​/Managers, QA Specialist - Analyst​/Manager

Scientist

The Scientist plays a key role in ensuring product quality, regulatory compliance, and operational efficiency within a laboratory and manufacturing environment. This position focuses on analytical testing of raw materials and finished goods, continuous process improvement, support for audits and FDA-related documentation, and leadership within the laboratory and audit space.

• Identify and recommend improvements to laboratory and production processes to maintain quality, cost effectiveness, safety compliance, and other performance parameters.
• Perform timely release testing on all incoming raw materials required for manufacturing and on finished goods, ensuring results are accurate and documented.
• Coordinate the scheduling of all materials to meet internal production and quality requirements.
• Ensure that assigned products consistently meet quality requirements for both customers and the organization.
• Draft clear, written reports detailing the results of testing and analytical activities.
• Approve the release of raw materials and finished goods based on established quality standards and test results.
• Proactively identify trends in laboratory analysis and operations, implement improvements, and communicate findings and recommendations to management.
• Perform operations in support of contract manufacturing organizations (CMOs) as needed.
• Operate and maintain laboratory equipment, identify issues when equipment fails, and conduct or recommend appropriate repairs.
• Perform routine maintenance and calibration of laboratory instruments and equipment as required.
• Conduct peer review of analytical results generated by colleagues to ensure accuracy and compliance with procedures.
• Perform peer review of test methods and protocols to maintain robust and reliable analytical practices.
• Review and draft standard operating procedures (SOPs) as needed to align documentation with current procedures and regulatory expectations.
• Author and execute written protocols, including IQOQ (Installation Qualification/Operational Qualification) documentation, as required.
• Cross-train to competently perform sample laboratory duties accurately and efficiently.
• Support audits and audit-related activities by providing laboratory data, documentation, and subject matter expertise on quality and compliance.

• Strong background in Chemistry, Biology, or related scientific discipline with practical laboratory experience.
• Expert-level proficiency with HPLC or UPLC techniques for analytical testing.
• Hands-on experience in analytical chemistry and wet chemistry within a quality control or laboratory environment.
• Demonstrated experience in laboratory operations, including sample handling, testing, and documentation.
• Excellent organizational skills and strong attention to detail to manage multiple tests, reports, and compliance requirements.
• Excellent time management skills with a proven ability to meet deadlines in a fast-paced setting.
• Strong verbal and written communication skills with the ability to collaborate effectively with all levels of management and external vendors.
• Strong analytical and problem-solving skills, including the ability to read and understand technical instructions and materials in English.
• Ability to function effectively in a high-paced and sometimes stressful environment while maintaining accuracy and composure.
• Thorough understanding of FDA regulations and cGMP compliance requirements.
• Working knowledge of regulatory expectations and quality standards to ensure products and production units meet required specifications.
• Proficiency with Microsoft Office Suite and virtual meeting applications.
• Experience using SAP Business One or similar enterprise resource planning software.
• Proficient computer skills, including basic spreadsheet functions and word processing.
• Working knowledge of scientific instrumentation and techniques relevant to analytical and quality control laboratories.

• Bachelor of Science degree in Chemistry, Microbiology, Biology, or a closely related scientific field.
• Experience supporting audits and audit management activities within a laboratory or manufacturing environment.
• Experience providing audit support and preparing documentation for regulatory inspections.
• Familiarity with FDA compliance documentation and processes.
• Ability to act as a senior individual contributor and informal leader within the laboratory and audit space.
• Comfort working with vendors and cross-functional teams to resolve quality and compliance issues.
• Ability to contribute to continuous improvement initiatives and drive enhancements in laboratory efficiency and data integrity.

This role is primarily based in a laboratory setting and involves regular movement throughout the facility to support audits and FDA-related documentation. The Scientist works closely with production, quality, and regulatory teams, operating and maintaining scientific instrumentation and computer systems. The…