is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA.
Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent. The Quality Assurance
Specialist is responsible for the quality assurance functions at Catalent, Madison. The position primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements by developing and implementing quality assurance policies.
This includes Identifying production, process, or product issues, documentation management, internal and external auditing, interfacing with clients and managing client quality relationship. Quality Assurance Specialist involves serving as the main point of contact for designated projects, collaborating both internally and externally across different functions. This includes aiding in the integration
of the client's program into Catalent quality management system and ensuring successful management of client expectations.
This is a full-time on-site salaried position, Monday - Friday, 8:00am to 5:00pm CST 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: Responsible for maintaining and enhancing the effectiveness of the Quality System through ensuring compliant preparation and execution of production Responsible for representing Quality Assurance as the primary contact for assigned projects, which includes cross functional internal and external collaboration, supporting integration of the client programs into the Catalent Quality Management System and ensuring effective management of client expectations Responsible for interfacing with the clients and managing internal communication to sustain and enhance the Client quality relationships Accountable for review and approval of project related documents such as Master Batch Production Records, technical transfer, and process characterization reports Accountable for review and approval of project related deviation investigation records Accountable for ensuring that Finished Products are manufactured and tested in a manner consistent with the applicable regulatory or client requirements Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance All other duties as assigned The Candidate: Requires Doctorate Degree in STEM discipline with minimum of 0 years related experience OR Master's degree in STEM discipline with minimum of 4 years related experience OR Bachelor's Degree in STEM discipline with minimum of 6 years related experience OR Associates Degree in STEM discipline with minimum of 10 years related experience.
Knowledge of c GMP, ICH, FDA, EMA regulations or guidelines. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 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 Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement 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 xyz X@. 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 xyz X@ for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
parts, gages, and other equipment, accepting material/product or referring for quality review based on findings. Prepare inspection reports; ensure material traceability. Initiate Nonconformances (NCR) and Supplier Corrective Action Reports (SCARs); facilitate Material Review Board (MRB) meetings.
Use a variety of fixed and variable measuring instruments. Monitor and coordinate Engineering Change Order (ECO) activity across the organization ensuring compliance with the Quality Management System (QMS); support QMS maintenance for compliance with FDA QSR, ISO 13485, and other regulatory requirements. Ensure compliance with electronic document control workflows. Coordinate QA/QC tasks with
cross functional teams across the organization: support product development teams; review Device History Records (DHRs) for completeness and accuracy; execute receiving procedures & support shipping activities.
Support and promote continuous improvement initiatives to meet business objectives. Perform miscellaneous duties and projects as assigned and required. Training, Skills, Knowledge and/or Experience Demonstrated ability to manage records, document controls, and change controls. Experience using precision measuring equipment. Experience interfacing with stockroom, production control, purchasing, and engineering personnel. Working proficiency with Microsoft 365 apps, experience using
ERP/MRP/PLM systems preferred. Experience in FDA QSR and/or ISO 13485 or other regulated industry environments preferred.
Experience working in a product development environment a plus. Experience with QMS internal auditing and Minitab usage a plus. Education Requirements High School Diploma or GED required. Bachelor's degree or equivalent level of education preferred. Minimum of 3 years of QA/QC related experience required. PI9dd44cd026d For more details: jobs-search. org/information-technology_gardner-c434575/quality-assurance-specialist-gardner_i1976023456
