Quality Control Analyst II

Catalent•Chelsea, MA

2d•Onsite

About The Position

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 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 (QC) Analyst II who is responsible for executing QC testing and related analytical activities supporting product development, release and stability. This person conducts routine and non-routine chemical and physical analyses of raw materials, in-process 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 out-of-trend and/or out-of-specification (OOT or OOS) results. This is a full time, salaried role. This is an on-site position, with core hours 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.

Requirements

Bachelor’s Degree required. Preferably in Physical or Chemical Sciences (life sciences) with a minimum of two years of relevant work experience required
Minimum of 1 year of regulated Good Manufacturing Practices (GMP) environment experience required
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

Nice To Haves

Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred
Ability to troubleshoot and repair analytical instrumentation such as HPLCs and UPLCs preferred
Experience with analytical method development and validation preferred

Responsibilities

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. Liquid Chromatography such as HPLC, UPLC, Gas Chromatography (GC), UV-vis, FTIR, laser diffraction, Karl Fischer)
Statistically and critically analyzes data for trending and reporting into regulatory filings
Participates in Laboratory and/or Quality Investigations and construction and/or revision of Standard Operating Procedures (SOPs)
Monitors equipment and instrumentation used on a daily basis to ensure proper operation and calibration
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

Benefits

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 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
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