Specialist III, Quality & ComplianceSummaryCatalent Biologics 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 in Kansas City, MO and Research Triangle Park, NC, 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 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 for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.The Quality & Compliance group has oversight of internal and client audits as well as regulatory agency inspections, compliance and regulatory support initiatives, and process validation activities.
This is a full-time on-site position, Monday - Friday 8am-5pm.($2,000 Sign-On Bonus Available)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- 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 development and review of audit responses.
- Facilitates 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.
- Drives alignment and improvement initiatives, leading 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.
- Other duties as assigned.
The Candidate - Doctorate Degree in STEM discipline with minimum of 6 years related experience OR
- Master's Degree in STEM discipline with minimum of 8 years related experience OR
- Bachelor's Degree in STEM discipline with minimum of 10 years related experience OR
- Associate's Degree in STEM discipline with minimum of 14 years related experience.
- Ability to see and hear and read and write clear English and to use Excel, Word, and other office systems.
- Maintains data integrity and ensures compliance with company SOPs and specifications as well as cGMP, ICH, FDA, EMA regulations or guidelines.
- Ability to communicate effectively and follow/retain detailed written and verbal instructions in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, professionally and accurately.
- Ability to independently lead investigations, deviations and change controls and to problem solve and initiate, develop and execute corrective action.
- Ability to lead technical calls and discussions regarding investigations or other issues.
Physical Requirements- Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.
- Occasional stooping, kneeling, crouching, bending, carrying, grasping.
- Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.
- Must comply with EHS responsibilities for the position.
- Working conditions will be Heating Ventilation and Air Conditioned controlled.
- Ability to operate within a clean room environment as needed.
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
- 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. 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 ...@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.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 ...@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE.