Summary:

The Quality Control Analyst III plays a vital role in ensuring that the highest quality standards are met throughout the development and commercialization phases. This position involves executing both routine and non-routine testing, assisting with method transfers, method validation, and supporting laboratory operations. The analyst will also contribute to data trending, investigations, and laboratory maintenance. This position is critical in supporting continuous operational schedules and upholding regulatory compliance within the Quality Control department.

Responsibilities:

• Perform routine and non-routine analytical and microbiological assays to support raw materials, in-process samples, product release, and stability studies, in adherence to SOPs
• Support weekend laboratory operations to ensure seamless testing schedules (Analytical, Microbiology, Raw Materials)
• Maintain accurate and up-to-date training records and adhere to testing schedules to ensure timely completion of tasks
• Assist in the maintenance of laboratory equipment and inventory, including reagent and sample preparation
• Review data in a timely manner and qualify as a data reviewer to ensure data availability and efficiency
• Perform role-specific operational tasks, including raw material processes (SAP transactions), environmental monitoring, and in-process testing
• Contribute to the revision of controlled documents, including SOPs, work instructions, and test methods, to ensure compliance with industry and regulatory standards
• Adhere to internal and regulatory standards (e.g., GMP, GLP, ICH guidelines) to maintain quality and compliance
• Participate in continuous improvement initiatives by identifying areas for enhancement in laboratory processes
• Collaborate with QC and cross-functional teams to ensure effective quality control operations and alignment with organizational goals
• Participate in the preparation of technical documentation for regulatory submissions, ensuring data accuracy and compliance
• Support inspection readiness activities, including assisting with audits and inspections as needed
• Engage in continuous training and development to improve expertise in QC testing and regulatory compliance
  
  
  

Requirements

Qualifications:

• B.S. in Chemistry, Biology, Microbiology, Biochemistry, or a related scientific field
• At least 4 years of experience in a GMP Quality Control function within the pharmaceutical/biotech industry, or equivalent relevant experience
• Experience in method transfer, analytical method implementation, and lifecycle management
• Experience with HPLC/UPLC with Empower software
• Experience with Bioburden, endotoxin, conductivity, TOC
• Strong technical writing skills, particularly in investigation documentation
• Proficient in data analysis and interpretation with attention to detail
• Strong problem-solving skills, including conducting investigations and implementing corrective actions (CAPA)
• Excellent organizational skills with the ability to manage multiple tasks autonomously
• Effective communication and teamwork abilities to work collaboratively with cross-functional teams
• Proficiency in LabWare LIMS, Microsoft Excel, Word, and PowerPoint is preferred
  
  
  

Additional Information:

• Flexibility for weekend and occasional off-site responsibilities is required
• Ability to participate in a continuous operational schedule, including weekend work, is essential
  
  
  

Shifts: Friday, Saturday, Sunday and Monday