QC Analytical Scientist

About the role

This role performs routine and non-routine analytical testing of pharmaceutical products, raw materials, validation, stability, and process samples within a GMP-regulated laboratory.

Responsibilities

• Independently manage testing priorities
• Operate and maintain analytical instrumentation
• Evaluate data for accuracy and compliance
• Ensure complete and accurate documentation
• Collaborate closely with Quality Operations and may interact with manufacturing, engineering, environmental health and safety, technical services, research teams, and external laboratories as needed
• Support investigations, corrective actions, inventory management, material ordering
• Maintain laboratory compliance while delivering reliable, high-quality analytical results that support site operations
• Utilize laboratory instruments and equipment in accordance with established procedures (appearance hoods, pH meters, conductivity meters, Solo VPE, Osmometers, UV-VIS, HPLC, UPLC, TOC and conductivity, and various other instruments)
• Responsible for appropriate creation, review and approval of GMP documentation (test records, validation protocols/reports, test methods, equipment records, etc.)

Qualifications

Minimum Qualifications:

• BS in Chemistry or Biochemistry with a minimum of 2 years of experience working in a laboratory environment, QC laboratory preferred
• Experience working with analytical standards, reagents, and laboratory instruments
• Successful hands-on analytical testing experience in a Good Manufacturing Practices (also cGMP) environment
• Understanding and performing analytical testing and the use of analytical equipment: i.e. UV-VIS, HPLC, UPLC, pH, appearance, osmolality, TOC and conductivity
• Capability to perform complex mathematical problems and perform complex data analysis
• Accurate pipetting skills
• Strong organizational skills and ability to multi-task across projects and activities
• Must be self-motivated and work with minimal direction

Preferred Experience:

• Empower 3, LIMS
• Demonstrate proficiency in computerized systems, such as Laboratory Information Management System
• Must be authorized to work in the United States indefinitely without restrictions or sponsorship

Schedule

Position is full-time, Monday-Friday, generally 8 a.m. - 5 p.m., weekend work might be expected. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply. The site is not accessible by public transportation options.

Benefits

• Comprehensive medical coverage
• Dental options
• Vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays