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

Job Title:

Scientist

Job Description

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.

Responsibilities

+ 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.

Essential Skills

+ 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.

Additional

Skills & Qualifications

+ 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.

Work Environment

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…