QC Analyst II

Sun Pharmaceutical Industries • Billerica, MA

108d

About The Position

As a Quality Control Analyst II, you will play a critical role in ensuring the integrity and safety of our pharmaceutical products. You'll conduct analytical testing on raw materials, in-process samples, and finished goods, adhering to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs). This position offers the opportunity to work with cutting-edge laboratory equipment and contribute to the continuous improvement of our quality systems.

Requirements

• Bachelor's degree in Life Sciences or a related field.
• 2-4 years of hands-on experience in a pharmaceutical quality control environment.
• Strong understanding of chemical principles, wet chemistry, and analytical techniques (e.g., titration, limit tests).
• Proficiency in operating and troubleshooting laboratory instruments.
• Familiarity with Trackwise, Novatech, and Empower software.
• Excellent written and verbal communication skills.
• Detail-oriented with strong analytical and problem-solving abilities.
• Knowledge of cGMPs, GLPs, and regulatory compliance standards.

Responsibilities

• Perform release, stability, validation, and complaint follow-up testing on raw materials and finished products.
• Execute analytical assays using USP and EP test methods, ensuring compliance with GLPs.
• Operate and maintain complex laboratory instrumentation and systems (e.g., water systems, environmental chambers).
• Analyze and interpret test data; maintain accurate records in accordance with Good Documentation Practices (GDPs).
• Revise and update SOPs to reflect current practices and regulatory requirements.
• Coordinate with contract laboratories for sample testing and data collection.
• Prepare reagents, solutions, and equipment for chemical testing; clean and maintain lab glassware.
• Train junior analysts in laboratory techniques and procedures.
• Participate in monthly equipment maintenance and cleaning schedules.
• Support visual inspection qualification training and other assigned duties.

Benefits

• Medical, dental and vision coverage
• Life insurance
• Disability insurance
• 401(k) savings plan
• Flexible spending accounts
• Employee assistance program
• Paid time off benefits, including vacation time and sick time

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree