Quality Control Analyst II

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 lifecycle supply. With timetested experience in development sciences delivery technologies and multimodality 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 lifeenhancing and lifesaving treatments for patients annually.

The Bostonarea facility is Catalents 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 commercialscale lines for capsule filling and blister packaging. Onsite spray dryers include bestinclass 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 who is responsible for executing QC testing and related analytical activities supporting product development release and stability. This person conducts routine and nonroutine chemical and physical analyses of raw materials inprocess materials and drug products according to standard operating procedures. The Quality Control Analyst 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 outoftrend and/or outofspecification results.

This is a full time salaried role. The core hours are Monday Friday 8:00AM 4:30PM.

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

The Role:

• Performs analytical testing of spray dried powder using relevant methodologies (i.e. Delivered Dose Anderson Cascade Impaction Next Generation Impaction);
• Operates analytical instrumentation (i.e. HPLC UPLC GC UVvis FTIR laser diffraction KF);
• Statistically and critically analyzes data for trending and reporting into regulatory filings;
• Participates in Laboratory and/or Quality Investigations;
• Monitors equipment and instrumentation used on a daily basis to ensure proper operation and calibration.
• Participates in the construction and/or revision of SOPs;
• Assists in the writing and updating of analytical test procedures protocol log books and checklists;
• Responsible for identifying and alerting a supervisor of issues on instruments and/or test executions; makes initial recommendations for possible solutions and/or corrective actions;
• All other duties as assigned

The Candidate:

• Bachelors Degree required. Preferably in Physical or Chemical Sciences (life sciences) with a minimum of 2 years of relevant work experience required;
• 1 years regulated GMP environment experience required;
• Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred;
• Extensive experience with executing 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;
• Experience with analytical method development and validation preferred;
• Individual may be required to sit stand walk regularly and occasionally lift 50 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 fastpaced work environment
• Community engagement and green initiatives
• Generous 401K match
• Company match on donations to organizations
• Medical dental and vision benefits effective day one of employment
• Tuition Reimbursement Let us help you finish your degree or start a new degree!
• WellHub program to promote overall physical wellness
• Perkspot offers exclusive or private discounts from approximately 900 merchants in a wide array of categories