QC Analyst II – Analytical Separations

Bora Biologics USA LLC; Rockville (MD); On-site; USD 74,000 - 87,000; Full time

Benefits offered by this job

Competitive salary

Health coverage

Retirement savings

Paid time off

Professional development

Wellness programs

Employee Assistance Program

Job summary

Bora Biologics USA, LLC is seeking an analytical testing specialist to support cGMP-compliant testing for in-process, release, and stability samples. You will perform HPLC, CE, icIEF, and related analyses, enter data in LIMS, and help ensure data integrity.

Responsibilities include approving results, investigating out-of-spec findings, and supporting CAPAs. The role requires strong SOP adherence and collaboration within a quality-driven team in Rockville, MD.

Qualifications

• Requires High School Diploma with 4+ years in analytical/chemistry testing.
• Associate’s degree with 3 years related experience or Bachelor’s with 2+ years.
• Experience in HPLC, CE, icIEF, Subvisible Particle analysis, UV absorbance, pH, conductivity, osmolality.

Responsibilities

• Perform routine analytical testing for in-process, release, and stability samples.
• Enter data into LIMS and ensure data integrity.
• Peer review data and report out-of-spec results to supervisor.

Skills

analytical testing

HPLC

CE

icIEF

Subvisible Particle analysis

LIMS

GMP testing

data integrity

CAPAs

SOPs

Education

High School Diploma

Associate’s degree in scientific field

Bachelor’s Degree in scientific discipline

Tools

GMP testing equipment

Job description

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.

Essential Functions

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

Responsibilities and Job Duties

• 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.

Minimum Education, Experience & Skills

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

Compensation and Benefits

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer matching contributions
• Paid time off
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources

Core Values

At Bora, our values guide everything we do — from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.

Bora Pharmaceuticals is focused on developing and manufacturing branded, generic and over the counter (OTC) healthcare and pharmaceutical products for patients around the globe.

At Bora Pharmaceuticals, we see it as our mission and our duty to make our mutual success more certain. As an ambitious, future-focused company, we know better than most that our own success is shaped by our partners victories.