Quality Control Analyst, HPLC

What You'll Do

• Perform GMP release testing in Quality Control including, but not limited to, raw materials and finished product assay and identification by HPLC 
• Participate in analytical method transfer and method qualification
• Perform drug product testing to support formulation and process development
• Maintain accurate records of laboratory studies
• Work simultaneously on multiple projects
• Manage and operate QC Laboratory equipment in a cGMP-compliant manner
• Maintain inventory of all laboratory supplies and equipment and coordinate with the procurement manager to order and receive supplies
• Perform maintenance of laboratory equipment
• Perform related duties, as assigned
• Clean glassware used for testing and maintain laboratory cleanliness 


Qualifications
• BS in Chemistry, Pharmaceutics or Chemical Engineering
• A minimum of 1-3 years of HPLC experiment
• Working knowledge of laboratory instrumentation like HPLC, Karl Fisher and pH meters
• Knowledge of chromatography data systems, such as Waters Empower, or other laboratory software.
• Computer literacy in Windows applications and MS Office.
• Demonstrated excellent technical writing and verbal communication skills.
• Maintain a safe working environment, ensuring compliance to all local, state and federal regulations.
• Excellent attention to detail, compliance and quality
• Self-motivated individual with the ability to learn, lead and contribute to the team.


The ideal candidate will be familiar with USP, US FDA 21 CFR guidelines, US FDA guidance and, ICH guidelines for prescription pharmaceutical small molecules.


The candidate must have excellent time management, organization and planning skills. The individual must be able to multi-task, prioritize and manage timelines in a fast-paced environment. The ideal candidate will have the ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects.


Perks
• 100% company-paid Medical, Dental, Vision premium coverage plus Short-Term Disability and Life Insurance.
• 401K with company match to secure your future.
• Paid time off and company-paid holidays to help you unwind.
• Enjoy free daily lunch to keep you energized and focused.