Quality Control Scientist

Quality Control Scientist Golden, CO Job Details Full-time $75,000 - $90,000 a year 1 day ago Benefits Health insurance Dental insurance Paid time off Vision insurance Qualifications Biotechnology Teamwork GMP Bachelor's degree Organizational skills

Manufacturing Full Job Description Job Title:

Quality Control Scientist Location:

Vitro Biopharma - Golden, CO Position Summary The Quality Control (QC) Scientist supports cGMP manufacturing operations by performing and overseeing analytical testing for release, stability, and in-process control of cell-based products within a regulated environment. This role is responsible for executing methods, verifying and validating methods, developing and qualifying new analytical techniques, and ensuring all testing and documentation comply with regulatory requirements and internal Quality Management System (QMS) standards. The ideal candidate brings strong technical expertise in cell-based and molecular assays, experience in a cGMP QC laboratory, and the ability to operate independently while collaborating cross-functionally with Manufacturing, Quality Assurance, and R D teams. Key Responsibilities 1. QC Testing & Laboratory Operations Perform routine quality control testing for raw materials, in-process samples, and final product release in accordance with approved methods and specifications Execute stability studies following established protocols and timelines Conduct cell-based, biochemical, and molecular assays (e.g., flow cytometry, ELISA, PCR, electrophoresis) Ensure accuracy, reliability, and reproducibility of test results 2. Method Development, Transfer & Qualification Develop, optimize, and implement analytical methods for product characterization and QC testing Transfer methods from R D into cGMP-compliant QC environments Author and execute method qualification and verification/validation protocols Generate reports summarizing method performance and verification/validation outcomes 3. Documentation & Data Integrity Maintain accurate, complete, and compliant documentation including test records, laboratory notebooks, and electronic systems Adhere to Good Documentation Practices (GDP) and data integrity principles (ALCOA) Review data for accuracy and ensure compliance with SOPs and regulatory expectations 4. Quality Systems & Compliance (cGMP & ISO) Follow all Standard Operating Procedures (SOPs) and cGMP regulations Support investigations related to deviations and out-of-specification (OOS) results Participate in CAPA activities and continuous improvement initiatives 5. Equipment & Laboratory Maintenance Operate and maintain analytical laboratory equipment Support equipment qualification and preventive maintenance programs Troubleshoot instrumentation and assay performance issues 6. Cross-Functional Collaboration Partner with Manufacturing to support in-process testing and batch release timelines Collaborate with Quality Assurance on batch disposition and documentation review Interface with R D for method development, transfer, and process improvements

Qualifications Education & Experience:

Master's degree in Biology, Chemistry, Engineering, or related field preferred (Bachelor's with significant experience considered) 5+ years of experience in Quality Control within a cGMP-regulated biotechnology or pharmaceutical environment

Additional Skills:

Excellent attention to detail and organizational skills Strong written and verbal communication skills Proficiency in Microsoft Office (Word, Excel, PowerPoint); experience with electronic documentation systems preferred Ability to manage multiple priorities in a fast-paced, regulated environment Working Conditions cGMP laboratory environment Routine use of personal protective equipment (PPE) required Extended periods of standing and performing laboratory procedures May require flexibility to support manufacturing schedules

Pay:

$75,000.00 - $90,000.00 per year

Benefits:

Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person