QC Scientist - Microbiology
Catalent, Bloomington Indiana
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 hereA Quality Control (QC) Scientist's primary duty is to provide quality control of critical utility systems, in-process, finished products, stability, cleaning process, and analytical method validation testing according to SOPs, cGMPs, and regulatory guidelines.In concert with Catalent's Patient First philosophy, Quality Control group contributes to this philosophy by ensuring the quality of data produced is consistent with expectations. This position is critical to the patient first philosophy because it confirms the testing is performed per procedure and all test results are within specifications.The Role* Performing and reviewing testing during phases of production* Providing technical peer review of testing data* Writing/revising technical documents including laboratory procedures, protocols and technical reports* Independently utilizing microbiological or analytical instrumentation such as TOC* Performing testing using methodologies such as PCR, Endotoxin, Bioburden and recognizing atypical/out of specification (OOS) results* Assisting in investigations to determine root cause and implement corrective and preventive actionsThe Candidate* Bachelor's degree in science field with 3-5 years of experience, including 1 year GMP experience or regulated industry* Master's degree in science field with 0-2 years of experience, including 1 year GMP experience regulated industry* PhD in science field with 0-2 years of experience, GMP experience preferred or other regulated industry* Must be able to read and understand English-written job instructions and safety requirements* Endotoxin and bioburden experience highly preferred* GMP experience preferred* Must be able to read and understand English-written job instructions and safety requirements.Catalent's standard leadership competencies that are used to interview and for Performance & Development:* Leads with Integrity and Respect* Delivers Results* Demonstrates Business Acumen* Fosters Collaboration and Teamwork* Champions Change* Engages and Inspires* Coaches and DevelopsCatalent's facility in Bloomington provides a fully integrated and unique model for process development, clinical and commercial mammalian cell culture manufacturing, formulation, parenteral drug manufacturing and packaging under one roof. The award-winning facility provides clinical and commercial bulk drug substance and drug product manufacturing, including liquid and lyophilized vials, and prefilled syringes, along with an array of support services. The Bloomington site is proud to offer the following:* Diverse, inclusive culture* Competitive salary with quarterly bonus potential* Educational assistance/reimbursement* On-site fitness center and wellness programs* Excellent on-site cafeteria* Robust Employee Referral ProgramCatalent 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 www.catalent.com/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 [email protected] 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.