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

Job Title:

Scientist

Job Description

The Scientist will perform analytical testing on client samples using UV/Vis spectroscopy, filtration techniques, and microscopy in a regulated laboratory environment. This role focuses on generating high-quality data while ensuring all work complies with FDA regulations and cGMP standards. It is an excellent opportunity for professionals from pharmaceutical, medical device, biotech, contract testing, or other regulated laboratories who want to contribute to the expansion and build-out of a growing testing facility.

Responsibilities

+ Perform analytical laboratory testing on client samples by following established standard operating procedures (SOPs) and approved test methods.

+ Analyze samples using UV/Vis spectroscopy to generate accurate and reliable quantitative and qualitative data.

+ Conduct filtration testing, including membrane filtration, particulate evaluations, and related filter integrity assessments.

+ Use microscopy to examine and identify particles, contaminants, and key sample characteristics.

+ Record and review laboratory data in compliance with cGMP and Good Documentation Practices (GDP), ensuring data integrity and traceability.

+ Maintain accurate laboratory records and enter results into laboratory information management systems (LIMS) or electronic lab notebooks (ELN) when applicable.

+ Ensure all testing activities align with FDA and other relevant regulatory requirements and internal quality standards.

+ Prepare reagents, solutions, and standards needed for routine and specialized testing activities.

+ Maintain, calibrate, and troubleshoot laboratory equipment to support consistent and reliable operation.

+ Participate in investigations involving out-of-specification (OOS), out-of-trend (OOT) results, deviations, and other quality events.

+ Assist with updating SOPs and supporting audits, inspections, and continuous improvement initiatives within the laboratory.

+ Contribute to the ongoing expansion of testing services by supporting new methods, technologies, and process improvements as the laboratory grows.

Essential Skills

+ Bachelor's degree in chemistry, biology, materials science, or a closely related scientific discipline.

+ 1-3 years of hands-on laboratory experience in a GMP-regulated laboratory environment.

+ Industry experience performing UV/Vis spectroscopy for analytical testing.

+ Practical experience with filtration testing, including membrane filtration, particulate testing, and filter integrity testing.

+ Experience using microscopy to identify and characterize particles and contaminants in samples.

+ Familiarity with maintaining a lab notebook or working within an electronic lab notebook (ELN) system.

+ Working knowledge of cGMP requirements and Good Documentation Practices (GDP) in a regulated laboratory setting.

+ Ability to follow detailed SOPs and test methods accurately and consistently.

+ Strong attention to detail and commitment to data integrity and regulatory compliance.

Additional

Skills & Qualifications

+ Experience working in a contract testing laboratory environment.

+ Instrumentation experience with HPLC, FTIR, and particle sizing equipment.

+ Exposure to method validation or technology transfer activities within a regulated setting.

+ Prior experience authoring CAPA (Corrective and Preventive Action) investigations.

+ Familiarity with USP, EP, and ICH guidelines and understanding of FDA regulatory expectations.

+ Ability to support audits and contribute to continuous improvement initiatives in the laboratory.

+ Strong problem-solving skills and ability to participate effectively in OOS, OOT, and deviation investigations.

Work Environment

The role is based in a brand-new contract testing laboratory that focuses on supporting pharmaceutical and medical device clients. The team is in an early growth phase and is adding key roles to help build out the business and expand testing services. You will work with modern analytical instrumentation and laboratory systems in a cGMP-compliant environment, collaborating closely with other scientists and quality-focused professionals.

The setting offers the opportunity to influence laboratory…