Quality Control Analyst

Quality Control Analyst at ClinLab Solutions Group Quality Control Analyst at ClinLab Solutions Group in Cambridge, Massachusetts Posted in 8 days ago.

Type:

full-time

Job Description:

Seeking a Quality Control Analyst to support the advancement of a novel cell therapy product. This position involves hands-on laboratory work, technical documentation, and collaboration with a cross-functional team to support regulatory submissions and ensure compliance with industry standards.

Responsibilities:

Conduct a variety of assays for in-process, release, and stability testing of cell therapy products. Support the qualification of analytical methods to ensure reproducibility and suitability for intended use. Maintain detailed laboratory records in compliance with Good Documentation Practices and quality standards. Draft, review, and update standard operating procedures and other quality-related documents. Assist with investigations and documentation of deviations and out-of-specification results, including root cause analysis and corrective actions. Perform maintenance, calibration, and qualification of laboratory equipment to ensure regulatory compliance. Monitor inventory of laboratory supplies and reagents, ensuring a safe and organized work environment. Collaborate with technical teams to support the preparation of regulatory submissions and continuous improvement initiatives.

Qualifications:

Bachelor's or Master's degree in Biology, Chemistry, Biochemistry, Microbiology, or related Life Sciences field with 2-4 years of industry experience. Hands-on experience with mammalian cell culture, qPCR, and ELISA in laboratory or cGMP settings. Proficiency with Microsoft Office Suite and ability to learn new software quickly. Familiarity with aseptic technique, cell expansion, and cryopreservation workflows preferred. Understanding of cGMP, GLP, or

ISO 9001

environments highly preferred. Experience with equipment maintenance or qualification in a cGMP setting highly preferred. Demonstrated ability to maintain accurate and detailed laboratory documentation. Strong organizational and time management skills; ability to manage multiple tasks. Willingness to work a flexible schedule, including occasional weekends and holidays. Meticulous attention to detail in documentation and protocol execution. Self-motivated, strong work ethic, able to deliver high-quality work under tight deadlines, and thrive in a fast-paced team environment.