Quality Control Analyst III

Quality Control Analyst III

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 III who is responsible for executing QC testing and related analytical activities supporting product development, release, and stability. This individual conducts routine and non-routine chemical and physical analyses of raw materials, in-process materials, and drug products according to standard operating procedures and analytical test methods. The Quality Control Analyst III compiles data for documentation of test procedures that may include stability program testing and formulation studies, participates in the preparation of investigations, summaries and reports, and reviews data obtained for compliance to specifications and reports out-of-trend and/or out-of-specification results. The Quality Control Analyst revises and updates standard operating procedures as needed.

This is a full time, salaried role, Monday – Friday – days.

This is a full time, salaried role. This is an onsite position. The core hours are Monday – Friday 8:00AM – 5:00PM

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

• Perform analytical testing of spray dried powder (SDP) and spray dried dispersion (SDD) using relevant methodologies (i.e. Delivered Dose, Anderson Cascade Impaction, Next Generation Impaction, sample and solution preparation);  
• Operation of laboratory instrumentation (i.e FTIR, KF, TGA, HIAC, XRPD, UPLC, GC);
• Monitors equipment and instrumentation used on a daily basis to ensure proper operation and calibration. Perform troubleshooting and maintenance as needed;
• Author and/or revision and review of SOPs;
• Author and/or revision and of analytical test procedures, protocol, log books and checklists;
• Author, review, and execute Analytical Method Transfer protocols and reports;
• Perform peer review of analytical data;
• Train junior analysts on analytical methods;
• Author deviations and OOS investigations independently;
• Responsible for identifying and alerting a supervisor of issues on instruments and/or test executions;
• All other duties as assigned

The Candidate

• Bachelor’s Degree required; preferably in Physical or Chemical Sciences (life sciences).
• Minimum of five (5) years of relevant work experience required;   
• Three (3)+ years regulated GMP environment experience required;   
• Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred;
• Experience with executing QC test methods, generating associated data packages, auditing data packages generated by others, troubleshooting instrumentation required;
• Demonstrated ability to author investigations to determine root causes of OOTs and/or OOSs according to cGMP standards required;
• Demonstrated experience with analytical method development and validation preferred;
• Working knowledge of cGMP’s and their application to Quality Control required;
• Ability to effectively manage time and prioritize tasks independently to meet tight timelines and shifting priorities;
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Pay:

• The anticipated sa