QC Associate II (P-4985)

As a QC Associate II, you will be responsible for inspecting raw materials, intermediates, and finished goods. The role includes biological reagent, consumable testing plus instrumental quality control tasks. In addition to ensuring a reliable supply of quality products, you will be a key contributor to the development of manufacturing infrastructure required to support commercial products in the life science field.Success in this position requires strong initiative, adaptability, and teamwork within a fast-paced life sciences environment.

What you will be doing:

• Conduct quality control testing on raw materials, intermediates, and finished products according to established procedures.
• Perform molecular biology techniques, including PCR, next-generation sequencing, microscopy, cell and tissue based assays, and HPLC.
• Participate in instrument QC workflows, including training to work with mechanical stages and read technical drawings and first article inspection report.
• Accurately follow work instructions and standard operating procedures, while proactively identifying and reporting discrepancies.
• Maintain comprehensive and accurate records, including QC batch files and Receiving Inspection Reports, in accordance with Good Documentation Practices.
• Efficiently communicate complications identified during QC testing and collaborate with engineers and scientists to resolve issues.
• Initiate non-conformance, deviation reports, engineering change orders (ECO) and follow up on necessary action items. Ensure that lab operations and workflow execution are compliant with ISO requirements. Drive completion of investigations and minimize disruptions to QC operations.
• Assist in root cause investigations for non-conforming lots and contribute to continual improvement efforts.
• Support process and product development activities, including process optimization, guard band and stability studies, and gauge R&R.

Minimum Qualifications:

• B.S. in Biological Engineering, Molecular Biology, Analytical Chemistry, Chemical Engineering, or related discipline.
• 3 years of relevant laboratory experience in manufacturing and QC of life science products (e.g., PCR, NGS, protein analysis, HPLC).
• Willingness to rotate through various laboratory and administrative tasks and ability to prioritize workload, and adhere to deadlines.
• Proficiency in data entry using tools such as Excel, Oracle ERP and LIMS.
• Demonstrated ability to work both independently and as part of a team.
• Strong attention to detail, organization, and commitment to quality.
• Effective communication and observational skills.
• Excellent critical and logical thinking skills to analyze and troubleshoot issues.

Preferred Skills & Experience:

• Proficiency with data analysis tools (e.g. Retool, Tableau, GitHub, Snowflake)
• Extensive hands-on experience working within an ISO 13485 manufacturing environment.

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