QC Potency Analyst III

Bora Pharmaceuticals; Rockville (MD); On-site; USD 88,000 - 120,000; Full time

Benefits offered by this job

Competitive salary incentives

Health coverage

Retirement savings plans

Paid time off

Professional development opportunities

Employee wellness programs

Employee Assistance Program

Job summary

Bora Biologics is seeking a QC Analyst to support analytical testing programs to ensure cGMP compliance in in-process, release and stability testing. You will guide and partner with lower level QC analysts, ensure accurate documentation, and timely review of data while following SOPs.

The role involves performing ELISA, bioassays, and cell culture, along with basic methods, data entry in LIMS, and contributing to SOP updates and training.

Qualifications

• Bachelor's degree required.
• Minimum 4 years of experience in GMP/GLP-biotech pharma environments.
• Experience with ELISA, bioassays and cell culture preferred.
• Strong organization and ability to work independently in a fast-paced setting.

Responsibilities

• Perform routine analytical testing (ELISA, bioassays, cell culture) and basic methods (pH, conductivity, osmolality) per SOPs.
• Peer-review test data; identify deviations and trends for supervisor review.
• Investigate out-of-spec results and initiate CAPA/Quality event records.
• Update and develop SOPs; train junior analysts on methods.
• Oversee equipment calibration and maintenance; assist in troubleshooting.

Skills

GMP knowledge

Good Laboratory Practices

Mentoring

Analytical testing

Education

Bachelor's Degree

Job description

About Bora:

Bora Biologics is a global biologics CDMO delivering integrated development and GMP manufacturing solutions from FirstinHuman through licensed commercial supply. While many CDMOs are structured primarily for early clinical programs, Bora Biologics is purposebuilt for commercialization. Our inspectionproven, bicoastal 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 to ensure compliance with cGMP standards including in-process, product release and stability testing. This individual will guide and partner with lower level QC analysts to provide feedback and technical information. This individual will also ensure accurate documentation, timely completion of all analytical related testing, and timely review of data, while adhering to standard operating procedures and 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 complex methods such as ELISA, bioassays, and Cell Culture 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 to identify discrepancies and out of range results and to ensure adherence to standard operating procedures and GMPs. Identifies analytical data trends and reports findings and provides recommendation to supervisors for review and consideration.
• Conducts investigation when there are out of specification results from testing and reports to supervisor.
• 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.
• Develops, revises, and updates standard operating procedures, as needed.
• Collaborates with Senior QC team members to participate in the development, transfer, and validation of analytical testing methods and conducts training on analytical test methods to other QC Analysts as needed.
• Overseas lab equipment calibration and maintenance processes as required for testing per standard operating procedures, and raises any concerns about equipment to supervisor for resolution.
• Participates in troubleshooting of analytical test methods and instruments, as needed.
• Performs special projects related to problems encountered with analytical testing and instruments, and makes recommendations for solutions that will minimize future issues.
• Mentors and trains lower lever analysts, as needed.
• Prepares general lab solutions and buffers as needed and monitors expirations of these solutions and buffers.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

Education: Minimal formal education required ( Bachelor's Degree)

Experience: Minimum number of 4 years of experience is required

Knowledge: GMP: potency and residual testings and/or GLP ELISA, Bioassay, Quality Control.

Skills/Abilities: Working knowledge of good laboratory practices.

* Excellent understanding of GMPsrelated to the biotech or pharmaceutical industry

* Ability to organize and prioritize daily activities to meetinternal customer needs in a fast-paced

environment.

* Ability to work on extremely complex problems in which analysis ofsituation or data requires an in-depth

evaluation of intangible variables.

* Ability to act independently to determine methods and procedures on new assignments.

* Demonstrate the confidence to exercise independent judgment in developing methods, techniques, and

evaluation criteria for obtaining results.

* Demonstrating ability to coach and train others.

* Be able to work in a team environment in a cooperative and respectful manner.

* Ability to stand for periods of time when performing tasks on the floor.

* Ability to work a varied schedule including offshift and weekends.

* Ability to lift up to 50 pounds

Salary Range:

$88,000-$120,000

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

• 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.