Quality Control Analyst role at Catalent USA
This quality control job at Catalent offers an excellent opportunity for an experienced quality control analyst to support product development, release, and stability processes. Located in Chelsea, Massachusetts, this full-time on-site role gives you the chance to work with advanced analytical technologies while contributing to life-changing pharmaceutical products.
Job Details:
- Full-time, salaried Quality Control Analyst II position
- On-site role located in Chelsea, Massachusetts (02150)
- Work schedule: Monday to Friday, 8:00 AM – 4:30 PM
- Conducts routine and non-routine chemical and physical analyses
- Performs QC testing on raw materials, in-process materials, and drug products
- Supports product development, release, and stability programs
- Compiles data for documentation of test procedures and stability studies
- Participates in investigations, summaries, and technical reports
- Reviews test data for compliance with specifications
- Identifies and reports OOT (out-of-trend) and OOS (out-of-specification) results
- Works in accordance with standard operating procedures (SOPs)
- Uses advanced lab equipment including HPLC, UPLC, GC, FTIR, and more
- Contributes to continuous improvement and method updates
- Ensures compliance with GMP standards and Catalent’s quality culture
About Catalent:
Catalent, Inc. is a global CDMO dedicated to developing and manufacturing products that improve patient health worldwide. With over 40 global sites and thousands of experts, Catalent delivers innovative solutions across development sciences, delivery technologies, and multi-modality manufacturing. The Boston-area facility serves as the global Center of Excellence for spray dry dispersion and DPI capsule manufacturing. Apply for more quality control job opportunities in the USA.
Educational Requirements for Quality Control Analyst role:
- Bachelor’s Degree in Physical or Chemical Sciences (life sciences) required
- Minimum of 2 years relevant experience
- At least 1 year of experience in a regulated GMP environment
- Preferred experience with MDI/DPI analytical test methods
Key Responsibilities for Quality Control Analyst role:
- Perform analytical testing using methodologies such as Anderson Cascade Impaction and Delivered Dose
- Operate analytical instruments including HPLC, UPLC, GC, UV-vis, FTIR, and Karl Fischer
- Analyze and trend data for regulatory reporting
- Participate in laboratory investigations and SOP updates
- Monitor and maintain equipment calibration
- Prepare and update test procedures, logs, and checklists
- Identify issues in instrumentation and testing and recommend corrective actions
Skills Required for Quality Control Analyst role:
- Strong experience in QC test methods
- Ability to troubleshoot analytical instruments
- Experience with data trending and statistical analysis
- Knowledge of cGMP standards
- Ability to lead or author investigations for OOT/OOS results
- Experience in analytical method development and validation preferred
Benefits of the Role
- Defined career growth path
- Diverse, inclusive company culture
- 152 hours PTO + 8 paid holidays
- Medical, dental, and vision benefits from day one
- Tuition reimbursement
- Generous 401(k) match
- Employee resource groups and wellness programs
- Dynamic and innovative work environment
- Community engagement initiatives
