Analyst II, QC Analytical-3rd-Shift

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 Perform analytical testing per cGMP in support of raw material, in-process, final product, stability. This position will support our 3rd shift operations, working 10pm-6:30am.

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

• Perform various analytical testing procedures as per manufacturing/Quality Control batch records, Stability Protocols, etc.
• Perform analytical work per method transfer/ validation programs.
• Work with Project Managers and QA to ensure timely testing and release of samples.
• Perform instrumental analysis such as Karl Fischer, UV, HPLC and Gas chromatography.
• Inform supervisor upon observing out of specification results.
• Perform moderately complex test methods such as ELISA, etc.
• Participate in investigations of OOS results and other related studies.
• Participate in calibration, troubleshooting various types of equipment including proactive resolution of instrument issues.
• Write protocols and reports as necessary.
• Write and review SOP’s and Testing Standards as necessary.
• Assist in training other Analysts.
• Review, analyze, interpret and report data.
• Verifies and enters approved results in LIMS.
• Complies trend analysis and write associated reports for internal and regulatory use.
• Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
• Support department compliance and productivity goals.
• Track time worked per project.
• Participate in meetings as required.

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

• B.S. in chemistry or related field
• Minimum of 2-4 years in a GMP analytical chemistry laboratory

Technical/Professional Knowledge

• 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.

Base Compensation Range: 75000-113000

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.