Overview:
Our client is a global leader in custom chemical manufacturing, supporting the pharmaceutical, life sciences, and medical device industries. With a strong focus on innovation, quality, and customer partnership dedicated to helping its clients bring critical products to market safely and efficiently. They are now seeking a QC Analyst II to join their quality team and contribute to maintaining the highest standards in product testing and compliance.
Position Summary:
The QC Analyst II position is responsible for daily laboratory testing of raw materials, in-process, and finished products. In addition, this position is responsible for providing support for environmental testing, validation, stability, and other various laboratory and production testing.
Reports To: Laboratory Lead
Work Schedule: Shift work TBD/ Flexibility required/ Monday – Friday.
Role Responsibilities:
• Adhering to all Quality and Safety requirements on site and supporting Quality and Safety initiatives as required.
• Perform chemical testing using analytical instrumentation, including HPLC, GC, FTIR, UV-VIS, etc.
• Assist in sampling of raw materials upon receipt, when needed. Aid in maintaining quick turnaround time of raw material release.
• Familiar with Quality GMP documentation (hard copy and electronic) of testing results and assurance of laboratory data integrity.
• Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs.
• Experience with USP interpretation and testing.
• Support QC audit readiness with understanding of FDA and ISO regulations and requirements.
• Support on-time performance in the QC lab against the Production and laboratory schedules.
• Assist with maintenance and troubleshooting of QC lab equipment to minimize downtime.
• Assist with out of specification investigations.
• Maintain a safe, clean, and organized environment (5S) for all QC areas.
• Employ sound and compliant laboratory techniques and logic per industry standards (e.g., FDA, USP/NF, ISO, ANSI) and internal and customer requirements.
• Troubleshooting laboratory instrumentation.
• Review batch records to ensure they are compliant with SOPs, WIs, and GMPs
• Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices
• Any additional functions as assigned by the Laboratory Lead
EDUCATION
• Minimum of a Bachelor’s degree in Chemistry or related scientific field
• 4+ years of related experience.
EXPERIENCE
• Experience working in an ISO or FDA regulated environment preferred
• Familiarity with Empower
• Excellent communication skills, including the ability to speak clearly, listen and gain clarification, respond well to questions, and write clearly and informatively.
• Ability to deal with problems involving several concrete variables in standardised situations
ABILITIES
• Adherence to the company’s Guiding Principles; Integrity, Optimism, Honesty, Diligence, Stewardship, Humility and Shared Outcomes
• Proficiency with Microsoft Word, Excel and Access
Skills:
Analytical Instrumentation Proficiency, GMP & FDA Regulatory Compliance, Laboratory Documentation & Data Integrity
