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 Analyst II, QC Microbiology position supports the Quality Control group at Bora Pharmaceuticals Camden Campus to maintain process optimization and manufacturing activities. The Microbiologist is responsible for performing activities in support of the Microbiology, Environmental Monitoring, and Utility testing programs, which includes microbiological product testing, monitoring of the manufacturing production space, and supporting quality initiatives. The individual routinely conducts monitoring, testing, and SOP generation and revision.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Achieve gowning and aseptic qualification within 4 months.
• Maintains aseptic qualification and ability to support aseptic filling operations, up to 50% of time directly supports aseptic operations.
• Maintains gowning qualification.
• Perform various microbiological testing procedures as per Manufacturing/Quality Control batch records, stability protocols, raw material requests for testing, etc.
• Perform environmental monitoring and utility testing of the facility proficiently.
• Performs environmental monitoring during fill operations proficiently.
• Work with Project Managers and QA to ensure timely testing and release of samples.
• Inform supervisor/manager upon observing OOS, OOL, or generation of deviations
• Participate in investigations of OOS results and other related studies.
• Participate in validation, troubleshooting various types of equipment including proactive resolution of instrument issues.
• Investigate and suggest new laboratory procedures/techniques.
• Validate and implement new laboratory procedures/techniques.
• Update existing or write new testing standards and standard operating procedures.
• Train Microbiologist I & II in methods and techniques
• Review, analyze, interpret and report data.
• Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
• Support department compliance and productivity goals.
• Write and review monthly reports as necessary.
• Track time worked per project.
• Owns Change Controls and change actions.
• Authors deviation investigations.
• Proficient with document management system and owns updates to procedures.
• Perform Aseptic Technique/Contamination Control Training.
• Observe and report issues during filling operations.

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

To perform the job successfully, an individual should demonstrate the following competencies to perform the essential functions of this position.

Education: BS in Microbiology/Biology or related field

Experience: Minimum 2-4 years (MS with 0-2 years) in the Pharmaceutical or Biotechnology with emphasis in one of the following areas: aseptic processing, QC microbiology, environmental monitoring, water system, quality control, validation and manufacturing processes.

procedures.

• Technical/Professional Knowledge- having achieved a satisfactory level of technical and professional skill or knowledge in position-related areas; keeping up with current developments and trends in areas of expertise.
• Problem Solving- the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully.
• Safety and Security-the individual observes safety and security procedures and uses equipment and materials properly. May be required to lift items that are approximately 25lbs.
• Communication- Effective verbal and written communication, the ability to complete daily tasks as assigned, the ability to work independently and in a group, and the ability to multi-task. Speaks clearly and persuasively in positive or negative situations, demonstrates group presentation skills and conducts productive meetings.
• Quality Management- Looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.
• Planning/Organizing- Prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
• Adaptability - Maintains effectiveness when experiencing major changes in work tasks or the work environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
• Stress Tolerance- Maintains stable performance under pressure or opposition (such as time pressure or job ambiguity); handling stress in a manner that is acceptable to others and to the organization.
• Maintain attention to detail; have strong verbal communication skills with internal teams. Ability to succeed in a team-oriented environment under very dynamic conditions. Must be able to write legibly and accurately and contemporaneously record work in written and electronic form.
• Proven demonstration of qualifications related to Excel, Word, LIMS, or SAP systems is preferred, including course work.

Compensation range: 74,000 - 93,000

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.