QC Analyst II – Analytical Separations

About Bora:
Bora Biologics is a global biologics CDMO delivering integrated development and GMP manufacturing solutions from First‑in‑Human through licensed commercial supply. While many CDMOs are structured primarily for early clinical programs, Bora Biologics is purpose‑built for commercialization. Our inspection‑proven, bi‑coastal U.S. manufacturing platform and integrated development center provide the infrastructure, regulatory discipline, and operational precision required for sustained global market supply.

Job Summary:

This position is responsible for performing activities to support analytical testing programs at Bora Biologics USA, LLC. to ensure compliance with cGMP standards including in-process, product release and stability testing. This individual will be required to complete the testing and related documentation in a timely manner while adhering to standard operating procedures and under cGMPs.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Performs routine analytical testing including more complex methods such as HPLC, CE, icIEF, and Subvisible Particle analysis as well as basic methods such as concentration by UV absorbance, pH, conductivity, and osmolality, for in-process, product release, and stability samples on a daily basis in accordance with all protocols and procedures.
• Enters data into Laboratory Information Management System (LIMS).
• Performs peer review of test data generated by other analysts as needed to ensure data integrity and adherence to standard operating procedures and GMPs.
• Reports out-of-specification results from testing to supervisor and assists with performing laboratory investigations to determine the root cause and possible resolution.
• Initiates and monitors progress of analytical related Quality event records (e.g., Deviations and CAPAs) and conducts investigations to determine root cause and possible resolution.
• Performs routine lab cleaning and equipment maintenance activities in accordance with SOPS as scheduled, and escalates potential equipment issues to supervisor.
• Prepares general lab reagents and buffers as needed and monitors expiration dates.
• Identifies opportunities for process improvement and makes recommendations to team leader.
• Revises and updates standard operating procedures, as needed.
• May participate in special projects related to problems encountered with testing and instruments, and make recommendations for solutions that will minimize future issues.
• Performs other duties as assigned.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties.

Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

High School Diploma and minimum of four (4) years of experience in performing analytical/chemistry testing. Associate’s degree in a scientific area of study with three (3) years of related experience Bachelor’s Degree in a scientific discipline and minimum of two (2) years of direct related experience. Experience in one or more of the following areas required: HPLC, CE, icIEF, and Subvisible Particle analysis, UV absorbance, pH, conductivity, osmolality, Quality Control, and GMP testing.

Strong knowledge of good laboratory practices.

Salary Range: $74,000-$87,000

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer matching…