QC Analyst I - Flow Cytometry - Will train, no experience necessary

Job Summary

QC Analyst I performs flow cytometry for our Quality Control Analytical Department. The successful candidate will be responsible for performing routine quality control product and raw material release testing utilizing multi-color flow cytometry as well as various biochemistry, molecular biology, and general laboratory techniques according to GMP. Additionally, the analyst will assist QC Scientists with technology transfer of new client assays by Co-authoring SOPs or other required documentation.

• Perform routine in-process and final release assessments of products using multicolor flow cytometry
• Reviews test results of other QC analysts for accuracy and precision and maintains efficient workflow of all required testing documentation ensuring timely submission relative to product release dates
• Enters assay results into the appropriate trending databases for periodic analysis
• Assists the QC Team with maintaining proper overall operation of department (physical inventories, logs, documentation, filing, etc.)
• Maintains familiarity with QC-relevant cGMP guidance’s (CFR, USP, EP, ICH, etc.)
• Co-drafts new SOPs or other documentation, as required, in support of new procedures adopted by the QC Department, either internally or at client request
• Assists with the implementation of quality improvement initiatives for QC laboratory operations
• Participates in laboratory, OOS, CAPA or other investigations, as required
• Maintains laboratory supplies, media and reagents inventory
• Adheres to standard operating procedures and good documentation practices to ensure data integrity and traceability
• Responsible for assisting with routine laboratory upkeep and organization

Job Qualifications

• Bachelors or higher degree in the biological sciences or related field preferred
• At least 4 years relevant laboratory experience, preferred
• 1-2 years of experience in cGMP/FDA regulated industry, preferred
• Ability to work independently and as part of a team
• Demonstrated knowledge in “core” laboratory techniques (e.g. ELISA, cell culture/counting, PCR, etc.) and aseptic techniques required
• Detail-oriented with strong written and verbal communication skills
• Ability to problem-solve and troubleshoot as necessary

Previous experience running multi-color flow cytometry or familiarity with FACS Canto II flow cytometer or similar preferred but not required.

Compensation Data

The pay range for this position is $44,000 - $47,000.  Please note that salaries vary within the range based on factors but not limited to experience, skills, education and location.