You are viewing a preview of this job. Log in or register to view more details about this job.

Group Leader, Quality Assurance Documentation Systems

Position Summary:
 
Catalent Pharma Solutions in Kansas City, MO is hiring a Group Leader – Quality Documentation Systems.  This role is responsible for first-line leadership of the site Document Control and Records Center departments. The Group Lead will guide work performed by the departments to facilitate achievement of site goals and objectives; and will support and develop direct reports whose functions are to support and maintain applicable site quality systems.

This is a full-time, salaried role position: Monday – Friday, days.

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 

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
  • Facilitate the implementation and maintenance of documentation systems including CDMS, EDMS, and FileTrail
  • Management of department processes including controlled document revision, document issuance, document retirement, on- and off-site record archival, and record destruction
  • Creation/revision of SOPs, forms, and work instructions related to the above processes
  • Support and/or ownership of investigation of deviations related to department systems
  • Leadership of site Document Control department and personnel
  • Leadership of site Records Center department and personnel
  • Able to perform administrator functions within applicable software systems
  • Support and development of direct reports to enable to them to grow as contributors in their current roles and/or within the organization
  • Support other activities within the Quality Systems department, which may include providing compliance metrics for site and corporate management, supporting regulatory inspections, client audits, and other quality or regulatory activities as needed
  • All other duties as assigned
The Candidate
  • Requires a Bachelors Degree and at least three years of experience in GMP environment
  • Strongly prefer experience with document control and/or record archiving systems
  • Strongly prefer leadership and teambuilding experience
  • Excellent written and verbal communication
  • Must be organized, consistently meet deadlines, and display strong computer proficiencies
  • Strongly prefer experience with GMP compliance including but not limited to investigating deviations and root cause analysis
  • Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds
 
Why you should join Catalent:
  • Defined career path and annual performance review and feedback process 
  • Diverse, inclusive culture 
  • 19 days of PTO + 8 paid holidays
  • Dynamic, fast-paced work environment
  • 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 
  • Competitive salary with quarterly 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 
  • On-site fitness center and wellness programs