• QC Analytical Specialist I

    Catalent Pharma SolutionsWebster, TX 77598

    Job #1207626938

  • Job DescriptionPosition 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 herePosition SummaryThe QC Analytical Specialist I reports to the Supervisor QC.The QC Analytical Specialist will participate in the entire range of quality control activities: assay performance, qualification/validation of assays and laboratory equipment, and transfer of methods. This role will perform QC tests in accordance with instructions given by the QC Supervisor as well as perform daily responsibilities and document work according to Catalent (formerly MaSTherCell) current procedures and GMP rules.The Role+ Perform QC assays to evaluate the quality of the cell therapy products with a Good Manufacturing Practice (GMP) quality grade in an efficient way;+ Maintain open and effective communication with all other QC team members;+ Participate in technology transfer from the client under the supervision of QC as well as analytical method validation;+ Draft QC documents (Instruction (INS), Procedure (PRO), Form (FORM), General Specification (GSPE)), technology transfer (TT), development, validation reports under the supervision of QC Project;+ Interpret the obtained results and immediately alert the QC Project Leader or QC Supervisor in case of unusual event/result/out of specifications (OOS);+ Initiate deviation, OOS, change control (CHC) in connection with your work and perform necessary investigation;+ Implement curative and preventive actions (CAPA);+ Fill the certificates of analyses;+ Participate in audits and in routine and planned maintenance, calibration, and qualification of equipment when required;The Candidate+ Bachelor's Degree in Chemistry, Biochemistry, Clinical Chemistry, or Biology; or relevant experience in the fields of Biotech/Pharma/Cell Therapy with 0-2 years of industry experience;+ Experience in quality control of cells from human tissue origin preferred;+ Experience in current Good Manufacturing Practice (cGMP) environment preferred.+ Organizational, multitasking, problem-solving, math, statistical, interpersonal, written and oral communication skills, detail-oriented and ability to prioritize work;+ Must be able to work within multi-functional teams and function well in a fast-paced environment;Position Benefits+ Opportunity to work with a growing department with high visibility to Senior Leadership+ Medical, Dental, Vision and 401K are all offered from day one of employment+ 19 days of paid time off annually + 7 paid holidaysLeadership Competencies for Performance and Development+ Leads with Integrity and Respect+ Delivers Results+ Demonstrates Business Acumen+ Fosters Collaboration and Teamwork+ Champions Change+ Engages and Inspires+ Coaches and DevelopsCatalent 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. personal initiative. dynamic pace. meaningful work.Visit ~~~/careers to explore career opportunities.Catalent 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 ~~~. 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.Catalent = Catalyst + TalentYour 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. Catalent 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, or protected veteran status. 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 along with the job number and title to ~~~. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.