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Senior Quality Assurance Associate

Company: Catalent Pharma Solutions Inc
Location: Severn
Posted on: June 1, 2021

Job Description:

Position Overview: Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start hereSenior Quality Assurance Associate - Operations (Client QA)Position Summary Catalent Cell and Gene Therapy is looking to recruit a Senior Quality Assurance Associate-Operations ( Client QA) to join our growing team in Harmans, MD.Senior Quality Associate - Operations (Client QA) is responsible to provide Quality Assurance support real-time for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. Responsibilities include providing QA on the Floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA functions as needed. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.The Senior Quality Assurance Associate role is critical to our patients. The Senior Quality Assurance Associate main responsibility is to provide QA oversight and support to client projects making sure the process and document records are in compliance with patient safety in mind, executing with efficiency always. Quality, safety and on-time delivery is a must to be successful in this role!The Role Represents QA in client interactions and meetings. Primary responsibility is to provide QA oversight and support to client projects while working closely with QA Management to ensure QA support for GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product used for human consumption.Performs QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing.Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practiceReview and dispositions executed batch records and supporting documentation for completeness, accuracy and complianceAct as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.Act as QA reviewer for investigations, deviations and CAPA; with limited approval authority as designated by QA Management. Write, revise and approve GMP documentation as necessaryWorks cross-functionally with Project Management, Manufacturing, Facilities, and Quality Control in meeting projectParticipate in site quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary.The Candidate B.S. in a Life Sciences discipline+8 years' experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry . +6 years' experience in Quality Assurance/Quality Control functionStrong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish.Creative individual with excellent analytical, trouble shooting, and decision-making skillsAbility to quickly learn new and novel manufacturing processes supporting new clientsCatalent's standard leadership competencies that are used to interview and for Performance & DevelopmentLeads with Integrity and RespectDelivers ResultsDemonstrates Business AcumenFosters Collaboration and TeamworkChampions ChangeEngages and InspiresCoaches and DevelopsPosition BenefitsPotential for career growth within an expanding teamDefined career path and annual performance review & feedback processCross functional exposure to other areas of within the organization Medical, Dental, Vision, and 401K are all offered from day one of employment19 days of paid time off annually + 8 paid holidays 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 www.catalent.com/careers to explore career opportunities.C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.

Keywords: Catalent Pharma Solutions Inc, Severn , Senior Quality Assurance Associate, Other , Severn, Maryland

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