QC Analyst II – Analytical Potency

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

Benefits offered by this job

Competitive salary and incentives

Comprehensive health coverage

Retirement plan with employer matching

Paid time off

Professional development

Wellness resources

Employee Assistance Program

Job summary

Bora Biologics USA, LLC is seeking a detail-oriented lab professional to support analytical testing programs in a cGMP environment. The role involves in-process, release, and stability testing, data entry, and ensuring adherence to SOPs and GMP standards.

Responsibilities include performing ELISA, Bioassays, and Cell Culture, reviewing data, and assisting with investigations to determine root causes. This position requires strong lab practices and collaboration with QA and cross-functional teams.

Qualifications

• Experience with ELISA, Bioassays, and Cell Culture in a regulated lab.
• Knowledge of GMP testing and laboratory quality systems.
• Familiarity with laboratory documentation practices and SOPs.
• Experience entering data into LIMS or comparable LIMS-like systems.

Responsibilities

• Performs routine analytical testing and more complex methods for product release and stability.
• Enters data into Laboratory Information Management System (LIMS).
• Performs peer review of test data to ensure integrity and GMP compliance.
• Reports out-of-specification results and assists investigations into root causes.
• Maintains equipment and performs general lab housekeeping and reagent prep.
• Collaborates with QA to support quality records and SOP updates.

Skills

ELISA

Bioassays

Cell Culture

Quality Control

GMP testing

Good Laboratory Practices

Education

High School Diploma

Associate's degree in a scientific area

Bachelor's Degree in a scientific discipline

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 ELISA, Bioassays, and Cell Culture, as well as basic methods such as concentration by UV absorbance, pH, process residuals (e.g. Host Cell Protein, Protein A and PS80) using ELISA kits, for product release, and stability samples 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 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.
• 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 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.
• Writes and supports quality records (e.g., Deviations and CAPA) and conducts investigations to determine root cause and possible resolution.
• Participates in transfer for Potency and Process Residuals test methods.
• Performs lab housekeeping activities and collaborate with the team to receive the reagents.
• Coordinates with QA to support quality records, revision of SOPs and technical reports.
• Works collaboratively across functional groups and departments.
• Performs critical reagent qualifications as needed.
• Writes memos, compile data, trend data as needed.
• Ability to work in fast paced environment.
• Helps train other analysts as needed.
• Performs other duties as assigned.

Minimum Education, Experience & Skills

• High School Diploma and minimum of four (4) years directly related experience.
• 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 ELISA, Bioassays, Cell Culture, 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

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.