Quality Control Analyst IV

Quality Control Analyst IV

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The Boston-area facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.

Catalent Pharma Solutions is hiring a Quality Control Analyst IV who is a key analytical leader in a cGMP laboratory capable of both clinical development and commercial testing. This analyst is both a mentor and trainer to team members and serves as a backup to QC management.

This is a full time, salaried role, Monday – Friday 8:00AM – 4:30PM

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role

• Operates analytical instrumentation (i.e. HPLC, UPLC, GC, UV-vis, FTIR, laser diffraction, KF, etc) for GMP testing of materials and product, for method transfers/validation, and for investigational purposes in a compliant and efficient manner;
• Performs data review and reporting (CofAs, reports, etc);
• Statistically and critically analyzes data for trending and reporting in quarterly quality reviews and annual product reviews;
• Leads investigations for Deviations, OOS/OOT results, and Product Quality Complaints;
• Monitors equipment and instrumentation to ensure efficient laboratory operations;
• Authors/Reviews/Approves controlled documents such as SOPs, analytical test procedures, protocols, logbooks and checklists;
• Identifies and escalates both issues and opportunities for efficiencies on instruments and/or test executions; makes initial recommendations for possible solutions and/or corrective actions and implements solutions as appropriate;
• Trains and mentors team members on analytical instrumentation and material/product test methods;
• Leads team standup meetings and assists in laboratory scheduling;
• All other duties as assigned

The Candidate

• Bachelor’s Degree in Physical or Chemical Sciences (life sciences) required;
• Minimum of eight (8) years of experience in a cGMP regulated environment required;
• Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred;
• Extensive experience with executing GMP QC test methods, generating associated data packages, auditing data packages generated by others, troubleshooting instrumentation, trending data and statistical analyses required;
• Demonstrated ability to lead and/or author investigations to determine root causes of OOTs and/or OOSs according to cGMP standards required;
• Ability to troubleshoot and repair analytical instrumentation such as HPLCs and UPLCs preferred;
• Chromatography skills using Empower and/or ChemStation required;
• Critical understanding of the importance of documentation and data traceability required;
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
• 152 Hours + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Community engagement