QC Chemist III - DPI

Accountabilities:

• Quality Control Testing: Perform routine, advanced, and critical testing of pharmaceutical samples within an assigned laboratory group or department.
• Analytical Instrumentation: Operate specialized laboratory equipment and conduct analytical testing using instruments and techniques such as Karl Fischer, HPLC, GC, particle size analysis, and ICP.
• Raw Materials Testing: Apply working knowledge of raw material testing and release procedures to support quality and manufacturing requirements.
• Investigation Leadership: Lead laboratory investigations, analyze complex data, identify potential issues, and support appropriate resolution and follow-up activities.
• Regulatory Compliance: Ensure all laboratory activities comply with current Good Manufacturing Practices (cGMP), data integrity standards, established procedures, and applicable documentation requirements.
• Documentation and Data Integrity: Maintain accurate, complete, and traceable laboratory records in accordance with good documentation practices and internal quality standards.
• Scientific Analysis: Review and interpret analytical results, identify discrepancies, and support reliable, evidence-based quality decisions.
• Team Collaboration: Work effectively with laboratory colleagues and other departments, sharing technical knowledge and supporting team objectives.
• Additional Responsibilities: Perform other laboratory and quality control duties as assigned by the department or section leadership.

Requirements:

• Bachelor’s degree in a physical science or a related scientific discipline is required; a master’s degree is preferred.
• At least 8 years of relevant professional experience for a Chemist III-level position.
• Strong practical knowledge of pharmaceutical quality control testing, analytical procedures, and laboratory operations.
• Working knowledge of raw material testing and release processes.
• Experience with analytical instruments and techniques, including Karl Fischer, HPLC, GC, particle size analysis, and ICP.
• Experience with dry powder inhalation (DPI) products is an advantage.
• Strong understanding of cGMP requirements, data integrity principles, and good documentation practices.
• Proficiency in scientific English, including the ability to read, write, understand, and communicate technical and scientific information.
• Excellent analytical and organizational skills, with the ability to understand and interpret complex data sets.
• Strong teamwork, learning, and knowledge-sharing skills.
• Working knowledge of Microsoft Office applications and other scientific software.
• Willingness to work in a pharmaceutical laboratory or manufacturing and packaging environment and to use required personal protective equipment.
• Ability to work an assigned shift, which may include first or second shift schedules, occasional weekends, or holidays depending on business needs.
• Ability to meet the physical requirements of the role, including standing or walking for extended periods, working at a computer, wearing protective equipment, and lifting up to 10 kg when required.
• Work authorization: This position is open to local applicants only. Employment sponsorship and work visas are not available.
• Work arrangement: This is an on-site position in Hauppauge, New York; remote work is not available.

Benefits:

• Annual salary ranging from $96,000 to $103,000.
• Full-time professional position with a general shift of 8:30 a.m. to 5:00 p.m., subject to business needs and assigned schedules.
• Opportunity to work in a pharmaceutical quality control environment supporting high standards of product quality and safety.
• The original job description does not specify additional benefits such as healthcare coverage, retirement plans, or paid time off.