Quality Control Analyst IV

Catalent; Chelsea (MA); On-site; USD 70,000 - 95,000; Full time

Job summary

An established industry player is seeking a skilled Quality Control Analyst IV to join their Boston-area facility, a hub for inhalation product manufacturing. In this pivotal role, you will lead analytical testing in a cGMP laboratory, mentor team members, and ensure compliance with stringent quality standards. This innovative firm offers a dynamic work environment with ample career development opportunities and a commitment to improving patients' lives through advanced drug development and manufacturing. If you are passionate about quality control and ready to make a significant impact, this is the opportunity for you.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401K Match

Tuition Reimbursement

Wellness Programs

Career Development Opportunities

Performance Reviews

Diverse and Inclusive Culture

Innovative Work Environment

Qualifications

• 8+ years of experience in a cGMP environment with extensive QC testing experience.
• Strong documentation skills and ability to lead investigations per cGMP standards.

Responsibilities

• Operate analytical instruments for GMP testing and method validation.
• Lead investigations for deviations and monitor laboratory equipment.
• Train and mentor team members on analytical methods.

Skills

Analytical Testing

Data Analysis

Chromatography

GMP Standards

Team Leadership

Education

Bachelor’s Degree in Physical or Chemical Sciences

Tools

HPLC

UPLC

GC

UV-vis

FTIR

Empower

ChemStation

Job description

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Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) dedicated to developing, manufacturing, and supplying products that improve lives. Our Boston-area facility is a Center of Excellence for inhalation product manufacturing, featuring advanced spray drying and capsule filling lines. We are hiring a Quality Control Analyst IV to lead analytical testing in our cGMP laboratory, mentor team members, and serve as a backup to QC management.

Responsibilities

• Operate analytical instruments (HPLC, UPLC, GC, UV-vis, FTIR, etc.) for GMP testing, method validation, and investigations.
• Review and report data, including CofAs and reports.
• Analyze data statistically for trending and review in quality meetings.
• Lead investigations for deviations, OOS/OOT results, and product complaints.
• Monitor laboratory equipment and ensure efficient operations.
• Author, review, and approve controlled documents like SOPs and protocols.
• Identify issues and opportunities for efficiency, recommend and implement solutions.
• Train and mentor team members on analytical methods and instrumentation.
• Lead team meetings and assist with laboratory scheduling.

Qualifications

• Bachelor’s Degree in Physical or Chemical Sciences.
• At least 8 years of experience in a cGMP environment.
• Experience with MDI/DPI analytical methods preferred.
• Extensive GMP QC testing experience, including troubleshooting and data trending.
• Ability to lead investigations per cGMP standards.
• Chromatography skills using Empower and ChemStation.
• Strong documentation and data traceability skills.

Why Join Catalent

• Career development opportunities and performance reviews.
• Diverse and inclusive culture.
• Innovative work environment and growth potential.
• Comprehensive benefits including medical, dental, vision, 401K match, tuition reimbursement, and wellness programs.

Join us to make a difference in patients’ lives through innovative drug development and manufacturing. Visit Catalent Careers for more opportunities.