Specialist Iii - Madison, United States - Catalent

Catalent
Catalent
Verified Company
Madison, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Specialist III, Quality Assurance, Systems

M-F 8am-5pm

Summary


Catalent 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, sitewide 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 Assurance Systems group has ownership over the quality systems, including deviations and CAPAs, change controls, document control, supplier quality management, raw material testing and disposition, and training, as well as oversight of the equipment calibration and preventive maintenance program and validation activities._

The Role

  • Accountable for the Investigation and CAPA Management Systems.
  • Responsible for managing complex and highlevel deviations, supporting OOS investigations, and collaboration with internal Catalent stakeholders to support the effective execution of the Investigation and CAPA systems.
  • Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification, and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support Deviation, OutofSpecification and CAPA processes.
  • Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations.
  • Provides technical assistance and training for personnel.
  • Files and maintains controlled documents.
  • Other duties as assigned.
  • 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

  • Associates Degree in STEM discipline with minimum of 14 years related experience.
  • Ability to use Excel, Word, and other office systems.
  • Prior work experience with quality management software such as TrackWise or ComplianceWire.
  • Maintains data integrity and ensures compliance with company SOPs and specifications as well as cGMP, ICH, FDA, EMA regulations or guidelines.

Position Benefits**:


  • 19 days PTO & 8 Holidays
  • Medical, Dental & Vision Benefits and 401k
  • 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.

Important Security Notice to U

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