QC Analyst 3

Title: Senior QC Analyst – Analytical Testing
Location: Portsmouth, NH (Onsite) 
Duration: 8 Months Assignment with a Chance of Extension 
 

Job Summary

The QC Analyst IV will support in-process and final product testing, customer stability studies, and daily QC laboratory operations in a cGMP environment. This is a senior-level position responsible for analytical testing, equipment troubleshooting, investigations, Data Integrity, and audit readiness, while also providing guidance to junior analysts.

Key Responsibilities:

·       Perform and review analytical QC assays for in-process and final products.

·       Support HPLC and Electrophoresis laboratory activities and advanced assays.

·       Troubleshoot laboratory equipment and software and coordinate maintenance/calibration activities.

·       Support investigations, change controls, work orders, and process improvements.

·       Maintain cGMP, Data Integrity, and laboratory compliance.

·       Support audit/inspection readiness and serve as a QC SME when needed.

·       Collaborate with Manufacturing, QA, MSAT, PV, and QC teams.

·       Provide guidance and feedback to junior analysts.

·       Complete assigned work accurately, independently, and on time.

Required Qualifications & Skills:

·       Bachelor’s degree in Biochemistry or a related science field.

·       5–10 years of experience in QC/analytical laboratory functions.

·       Pharmaceutical/biopharmaceutical cGMP experience.

·       Strong hands-on experience with HPLC/UPLC and analytical testing.

·       Experience with assay execution and review.

·       Strong understanding of Data Integrity and quality compliance.

·       Experience with equipment troubleshooting, investigations, and audit readiness.

·       Strong data interpretation, problem-solving, written and verbal communication skills.

·       Ability to work independently with minimal supervision.

Preferred / Additional Experience:

·       Agilent or Waters HPLC

·       Capillary Electrophoresis / PA-800

·       Protein Simple iCE3 / icIEF

·       SoloVPE / Cary 60

·       7500 Real-Time PCR

·       KingFisher Flex

·       Sysmex CS-2500

·       Immunology laboratory experience

·       Advanced assay execution/review

·       Experience mentoring or guiding junior analysts.