Quality Control Analyst II

Quality Control Analyst II Position Summary: The Quality Control Analyst 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. 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 results. The Quality Control Analyst revises and updates standard operating procedures as needed. This is a full time, salaried position Monday – Friday (Day Shift) Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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 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). 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, logbooks and checklists. All other duties as assigned. The Candidate Bachelor’s Degree in Physical or Chemical Sciences (life sciences) required. Minimum of 2-5 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 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. Familiarity with executing Standard Operating Procedures in a GMP setting required. Chromatography skills using Empower and/or ChemStation required. Critical understanding of the importance of documentation and data traceability required. Working knowledge of cGMP’s and their application to Quality Control required. Excellent oral and written communication skills. Ability to effectively manage time and prioritize tasks independently to meet tight timelines and shifting priorities. Demonstrates dedication to documentation/data traceability and strong attention to detail. Demonstrates appropriate safety consciousness. 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 Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of paid time off annually 8 paid holidays Competitive salary with yearly bonus potential Community engagement and green initiatives 401K with generous match Medical, dental and vision benefits effective day one of employment Tuition reimbursement On-site fitness center and wellness programs Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. Catalent = Catalyst Talent Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us! personal initiative. dynamic pace. meaningful work. Catalent is the perfect place to grow your career if… You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT). You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world! You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people. You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first. You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU! See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.

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