(Sr.) Qc Analyst Jobs

Job Title: (Sr.) QC Analyst

Location: Will be working in Waltham, MA and Cambridge MA sites; team will move to Devens, MA in 2024;

Experience required:

• BS/MS expectation; will consider AS level folks if they are perfect everywhere else
• Must come from a QC background; experience with flow cytometry, HPLC, qPCR, ddPCR, and ELISA
• Will take someone on the junior end (will be a QC Analyst; not Sr. QC Analyst) with 2-4 years' experience; 5+ years of relevant experience is Sr QC Analyst level
• Cell Culture is an absolute must

Description

Our Client is seeking a Quality Control Senior Analyst to join the Quality Control team and play a significant role in the support of our product pipeline.

This position reports to the QC Manager, Internal Operations.

This position will be responsible for performing a variety of QC testing including, but not limited to, using Flow Cytometry, FTIR, Osmometer, Cellometer, NanoDrop, ImageStream, StemVision, UV-VIS, HPLC/UHPLC, qPCR/ddPCR, Plate reader, pH/Conductivity, Gel Electrophoresis and Compendial Methods.

This position will also be responsible for Method Validation and Transfer from Internal Analytic Development and/or External Testing Laboratories to Quality Control Internal.

This position will work at both QC sites in Cambridge and Waltham facility, MA.

Key Responsibilities & Accountabilities:

Perform routine/non-routine testing of in-process, final product, raw material samples in accordance with Standard Operating Procedures, such as Visual Appearance Inspection, Flow Cytometry using BD FACS Canto, ID tests by FTIR, pH/Conductivity, Osmolality, Cell Count and Viability by Cellometer, Nucleic Acid concentration by NanoDrop, ELISA by Plate Reader, Colony count by StemVision, sickling reduction by ImageStream Analysis, HPLC/UHPLC, qPCR/ddPCR, etc.

Responsible for drafting, executing and reporting Method Validation and Transfer Protocols.

Responsible for generation, revise and review of other protocols, procedures (e.g. SOPs, Test Methods, FORMS) and report, as required.

Responsible for change controls, OOS and deviations, as required.

Assist sample shipment and result collection of external tests.

Communicates with internal analysts in QC and different departments, and with external contract testing laboratories for technical issues and make sound judgment and decision for problem solving.

Perform other duties, as assigned.

Requirements

Knowledge, Experience, Skills & Capabilities:

Hands-on experience minimally on following equipment/assays, but not limited to: Visual Appearance Inspection, pH, FTIR, Osmolality, K2 cellometer, Flow Cytometer, NanoDrop, Plate reader, HPLC/UHPLC, qPCR/ddPCR, ImageStream and StemVision.

Working experience on method validation and transfer.

Working experience in analytical/QC environment.

Working experience in compliance with cGMP’s, effectively demonstrates an understanding of cGMP's and how it applies to specific responsibilities.

Ability to work independently with skills for multi tests/projects.

Ability to collaborate, communicate, and work effectively in a team-oriented.

Good verbal and written communication skills.

Proficiency in the use of Microsoft Office (Word, Excel, PowerPoint, etc), electronic documentation and Traning systems.

Education & Relevant Work Experience:

Bachelor’s or Master’s degree in biology, chemistry or other life science.

At least 5-8 years of relevant industry experience in Analytical/Quality Control in a Pharmaceutical/Biotech GMP environment. Working experience in the fields of gene and cell therapies is a plus.

Authorization to work in the United States indefinitely without restriction or sponsorship.