QC Analyst II - Analytical Separations

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

Benefits offered by this job

Health insurance

Retirement plan with employer matching

Paid time off

Professional development

Wellness programs

Employee Assistance Program

Job summary

Bora Biologics USA, LLC seeks a detail-oriented analytical technician to support developmental and GMP testing programs. The role focuses on in-process, release, and stability testing with methods such as HPLC, CE, icIEF, and subvisible particle analysis.

The candidate will enter data into LIMS, review results, and help with investigations, deviations, and CAPAs while maintaining adherence to SOPs and cGMP requirements.

Qualifications

• Bachelor's degree in a scientific discipline with related experience.
• Associate's degree in a scientific area with related experience.
• High School Diploma with multiple years of analytical testing experience.
• Experience with HPLC, CE, icIEF, Subvisible Particle analysis, UV absorbance, pH, conductivity, osmolality, GMP testing, and GLP.
• Strong knowledge of cGMP and laboratory practices.

Responsibilities

• Perform routine analytical testing for in-process, release, and stability samples.
• Enter data into LIMS and review data for integrity.
• Assist with investigations and CAPAs as needed.
• Maintain equipment and perform routine lab cleaning and calibration.
• Revise SOPs and participate in special projects as required.

Skills

Analytical testing experience

LIMS data entry

GMP knowledge

HPLC

CE

icIEF

Subvisible particle analysis

pH measurement

Osmolality testing

Quality control

Education

Bachelor's Degree in a scientific discipline

Associate's degree in a scientific area

High School Diploma

Tools

LIMS software

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 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.

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

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.