The posting
About Bora
Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products.
From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide.
At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.
Job Summary
The Quality Control Microbiologist is responsible for performing microbiological laboratory activities, including microbial limits, sterility, bacterial endotoxins, and other microbiological assay testing for incoming raw materials, intermediates, and finished products; performing water quality monitoring; supporting production area environmental monitoring and in-process microbiological sampling (CV); performing and/or supporting laboratory equipment calibration and preventive maintenance; preparing and/or revising laboratory-related SOPs; and performing method verification and validation activities.
Responsibilities
- Performs Lab activities by following relevant present SOPs.
- Prepares and revises QC relevant SOPs, associated training materials.
- Prepares reagents that are to be used for the analysis.
- Records analytical data in notebooks, logbooks and Specification and Quality Assurance Report and laboratory analysis forms accurately. Records results in a trending monitor perspective.
- Performs calibration and preventive maintenance activities of Lab equipment.
- Analyses products, raw materials and stability samples according to laid down procedures in testing methods. Conduct analysis for microbial limits, microbial identification, environmental monitoring, etc. *Basic skills, ex. Micro: water testing, media preparation, bioburden, Endotoxin Chemical: pH, TOC); *Critical aseptic operation (Micro ID, aseptic EM, sterility testing, LAL)
- Calibrates equipment as required, in accordance with set methods and procedures.
- Alerts direct-manager or deputies verbally in the event of any result not meeting specification or of any questionable results generated.
- Ensures adequate stocking of Laboratory reagents and consumables, through monitoring re-order levels and timely notification to direct-manager or deputies.
- Supports investigative testing and investigation activities.
- Reviews test report, data packs.
- Prepares and revises relevant technical reports, such as annual purified water quality test report
- Prepares and revises test methods.
- Prepares and revises method verification protocols and reports
- Perform in a continuous improvement.
- Follows the training program schedule to complete the directed training courses.
- Performs certification activities in accordance with regulatory and industry requirements.
- Completes delegated tasks by the agreed completion date and treat as commitment.
- Other duties as assigned by the supervisors or company.
Qualifications
- Major in science or pharmaceutical science (pharmaceutical experience preferred). Major in microbiology education is preferred.
- Microbial Laboratory operation experience less than 2 years is required
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 contributions
- Paid time off and flexible work arrangements
- Professional development opportunities
- Employee wellness programs and resources
- Employee Assistance Program and Mental Health Resources
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.
