Senior Specialist II - Quality Assurance

Senior Specialist II - Quality Assurance

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 a Senior Specialist II - Quality Assurance.

The Quality Assurance Operations group has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping.

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.
• Responsible for final approval and disposition of finished product for shipment to customers.
• Maintains a high level of understanding of the quality systems and operations to provide consultation and
  guidance for Manufacturing personnel regarding execution of the Quality Management Systems.
• Develops and provides training to support the training program for QA and manufacturing on specific
  quality functions.
• Supports and enhances effectiveness of the quality system, including reporting metrics; developing,
  authoring and approving Standard Operating Procedures (SOPs); identifying improvement opportunities;
  implementing 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.
• Acts as the quality contact and Subject Matter Expert (SME) for Quality Assurance operations and
  Quality management of client programs.
• Provide program specific review of documents supporting process validation and regulatory filings.
• Lead continuous improvement projects for the Quality Assurance Operations department.
• Notifies Management of potential quality or regulatory issues that may affect product quality or
  regulatory compliance.
• Performs and supports any other tasks necessary to maintain the product quality and site CGMP
  compliance.

• All other duties as assigned
   

The Candidate:

• Doctorate Degree in STEM discipline with minimum of 2 years related experience.
  OR
•  Master's Degree in STEM discipline with minimum of 5 years related experience.
  OR
• Bachelor's Degree in STEM discipline with minimum of 7 years related experience.
• Ability to use Excel, Word, and other office systems.
• Prior work experience with quality management software such as TrackWise® or ComplianceWire®.
• Ability to independently apply GMPs to everyday work.
• Maintains data integrity and ensures compliance with company SOPs and specifications as well as cGMP,ICH, FDA, EMA regulations or guidelines.
• Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines.

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 [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.

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 [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.