QC Analyst I – Environmental Monitoring

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 in support of microbiology and environmental monitoring testing programs including monitoring of the manufacturing cleanrooms. 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
Collects routine environmental monitoring (EM) samples and water samples and performs plate enumeration daily in accordance with all protocols and procedures.
Performs water testing and other routine microbiology testing in accordance with standard operating procedures.
Enters sampling and testing data into laboratory data system and ensures adherence to standard operating procedures and CGMP requirement.
Performs routine lab cleaning and equipment maintenance activities in accordance with SOPS as scheduled and escalates potential equipment issues to supervisor.
Reports deviations and out of specification results from the sampling and testing to supervisor and assists with performing laboratory investigations to determine the root cause and possible resolution.
Revises and updates standard operating procedures, as assigned with guidance from senior analysts and/or supervisor.
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 one year experience in performing Environmental Monitoring and Microbiology testing.
Bachelor’s Degree in scientific discipline
Working knowledge of good in performing Environmental Monitoring or Microbiology testing.
Needs to be able to follow directions that are outlined in SOPs and other quality guidelines.
Ability to organize daily activities to meet internal customer needs in a fast-paced environment
Ability to understand when he/she should seek advice and guidance
Data entry skills
Salary Range:
$60,000-$75,000
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.