Specialist I - Quality Assurance Operations, Compliance

Specialist I - Quality Assurance Operations, Compliance Position Summary: Work Schedule: M-F 8am-5pm 100% on-site Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s. Catalent Pharma Solutions in Madison, WI is hiring Specialist I - Quality Assurance Operations, Compliance. The Quality Assurance department is responsible for all aspects of the quality assurance functions at Catalent, Madison. The department’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients. The Role: Executes internal audits, including coordinating the audit with relevant department subject matter experts, performing in-depth assessments of systems and procedures; communicating audit findings to key stakeholders; assisting with the review of audit responses. Supports customer audits, including coordinating audits with the customer and internal stakeholders; hosting audits and providing accurate information regarding the quality systems and operations; overseeing the audit response and follow up actions. Maintains facility licenses and registrations. Organizes documentation and facilitates review in support of client regulatory submissions. Monitors and assesses changes to regulatory guidance and compendial monographs. Supports and enhances effectiveness of the quality system, including reporting metrics; authoring Standard Operating Procedures (SOPs); identifying improvement opportunities; assisting with change control, risk management, and corrective and preventive action processes. Supports alignment and improvement initiatives, participating on cross functional teams to address process improvement, system improvement, and new regulations / expectations. Oversees customer Quality Agreements, including facilitating the development and approval of the agreements, ensuring accessibility of the agreements, and coordinating the revision and review of agreements. Drafts and executes technical plans, protocols, control strategies, and reports related to process validation and process monitoring (e.g., PPQ, CPV, APR / PQR). Maintains statistical tools to meet requirements for system and process monitoring and review. Maintains a sufficient understanding of the quality systems and operations to provide oversight and decision making. Files and maintains controlled documents. Other duties as assigned The Candidate: 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. Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Positive working environment focusing on continually improving processes to remain innovative Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of PTO + 8 paid holidays Generous 401K match Medical, dental and vision benefits effective day one of employment Tuition Reimbursement - Let us help you finish your degree or start a new degree! 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. 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 . 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 for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE .