QC Analyst II - Analytical Potency

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

Benefits offered by this job

Health coverage

Retirement plan

Paid time off

Professional development

Wellness programs

Employee assistance program

Job summary

Bora Pharmaceuticals in Rockville, MD is seeking an Analytical Laboratory Analyst to support analytical testing programs under cGMP, including in-process, product release, and stability testing.

You will enter data into LIMS, review data for accuracy, prepare reagents, assist with investigations, and help maintain SOPs and quality records while collaborating across teams.

Qualifications

• Requires High School Diploma with related experience or higher degrees.
• ELISA, Bioassays, Cell Culture and GMP testing experience.
• Strong knowledge of good laboratory practices.

Responsibilities

• Perform routine analytical testing incl. ELISA, Bioassays, and Cell Culture.
• Enter data into LIMS and prepare reagents and buffers.
• Review test data for accuracy and assist with investigations.
• H e l p maintain SOPs and quality records (Deviations, CAPA).
• Collaborate across teams and support transfers for tests.

Skills

ELISA

Bioassays

Cell Culture

Quality Control

GMP testing

Good Laboratory Practices

LIMS data entry

Education

High School Diploma

Associate's degree in science

Bachelor's degree in science

Tools

LIMS

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.

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.

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 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

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.