Actalent is Hiring a Quality Control Specialist

Job Description

The position involves reviewing all analytical reports and raw and electronic data from CMC, including various materials and equipment calibration. The role requires informing the CMC Manager and QA when tests are not within specified limits to take appropriate actions.

Responsibilities

• Ensure analytical data meets company standards and regulatory requirements.
• Review test results and raw data for various materials and stability samples, including assays, chromatographic purity, content uniformity, particle size distribution, density, and water determination.
• Check laboratory notebooks and associated documents for correctness and verify all reagents, standards, and equipment used.
• Review raw data for audit trails and instrument logs on cGMP instrumentation and equipment.
• Review validation and method optimization reports.
• Ensure chemists follow SOPs and cGMP regulations and use correct methods for each product.
• Promptly review notebooks and sign off on all analytical test results and reports.
• Analyze and interpret results in written and oral formats.
• Work with analysts for document corrections and provide guidance on laboratory notebook documentation requirements.
• Follow SOPs and Safety Guidelines to ensure compliance with cGMP environment and Safety Practices.
• Provide support during regulatory and internal audits.
• Review Laboratory Incidents, OOS, OOT, and OOE investigations.
• Perform additional tasks as assigned by the QA supervisor.

Essential Skills

• Proficiency in chemistry and quality control.
• Experience in data review and quality assurance.
• Familiarity with LC, GC, CAPA, and Change Controls.
• Bachelor's degree in Chemistry or related field.
• 4+ years of related experience in pharmaceutical analysis.

Additional Skills & Qualifications

• Experience with various analytical instrumentation, software, and tests performed in the lab, including HPLC, GC, Dissolution, Raw Materials, etc.
• Understanding of SOPs, USP/NF procedures, and requirements.
• Previous cGMP/regulatory experience is preferred.

Work Environment

This is an on-site role from Monday-Friday / both first and second shifts are available. The position generally involves standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking, and hearing. Occasionally, bending, kneeling, crouching, stooping, and crawling may be required.