QC Chemist - Pharma Manufacturing

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.
The QC Chemist II provides analytical and technical support for the analysis of raw materials (drug substances, excipients, in-process materials, and packaging components) stability samples, and drug products. Completes testing in a timely manner and according to cGMPs, Test Methods, and SOPs. Coordinates and leads special projects. Shows strong technical writing skills. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Evaluates testing due dates and project timelines to help prioritize appropriate testing and is willing to shift priorities to meet business needs.
Has an in-depth knowledge of laboratory instrumentation and software (HPLC, GC, UPLC, Empower, Biovia) and is proficient with administrative software (e.g., SAP, Veeva).
Documents testing using an analytical laboratory notebook (Biovia) or laboratory notebook and aids in maintaining the laboratory according to appropriate GMPs and SOPs.
Responsible for communicating atypical and out-of-specification results to laboratory management.
Independently authors laboratory investigations and laboratory deviations for management review.
Ensures a safe and clean environment in the laboratory. Maintains personal laboratory work area and assists with general laboratory cleaning.
Works independently or in a team setting with minimal supervision.
Communicates well with team members and helps junior analysts prioritize their work appropriately.
and other departments with minimal supervision.
Serves on project teams with support of laboratory management.
Can evaluate laboratory data to identify potential trends or shifts in product performance.
Displays a basic understanding of the regulatory impact of method changes, specification updates, etc.
Responsible for identifying and communicating the errors found in the documentation and testing.
Evaluates lab systems and processes. Independently revises the necessary documents and processes to implement changes.
Mentors' junior chemists on intermediate level instrument troubleshooting and quantitative testing. Provides training as applicable.
Proficient in a wide range of routine testing tasks. A Bachelor's Degree in Chemistry or related science field (with 12 credits of college chemistry) with typically a minimum of 6 years' related experience, preferably in the pharmaceutical industry.
Has experience working in a laboratory environment, preferably in the pharmaceutical industry.
Provides technical support/research to assist other departments as necessary.
Has experience or training in using Microsoft Word, Excel, and other computer software systems (e.g., Experience with SAP and Biovia is preferred.
Bora Pharmaceuticals offers a competitive total rewards and 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 Our Values At Bora, our values guide everything we do - from how we solve challenges to how we support our people.
Competitive salary and performance-based incentives
Comprehensive health coverage including medical, dental, and vision insurance
Retirement savings plans with employer matching contributions
Employee Assistance Program and Mental Health Resources
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.