 |
GMP Training Specialist - Quality Assurance - Chelsea Massachusetts
Company: Disability Solutions
Location: Chelsea, Massachusetts
Posted On: 11/17/2024
GMP Training Specialist - QA Position Summary: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.--The Boston-area facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.Catalent Pharma Solutions is hiring a Quality Systems Specialist (Training) who is responsible for administrative management and oversight of the site's training documentation and LMS.-- Work cross functionally to develop, improve and assign department curriculum based on changing needs of the site.-- Support site management through reporting of key training metrics.-- Create, implement and maintain a site Train the Trainer program.-- Identify and develop projects to adopt better practices from other Catalent site's.-- Provide support during site audits.This is a full time, salaried role, The core hours are flexible 8:00AM - 4:30PM Monday - Friday 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 - Serve as the Admin for ComplianceWire (LMS) and maintain employee training files/database;
- Processes training files by reviewing records for deficiencies and ensuring the documentation is in accordance with regulatory requirements, and resolving discrepanciesl
- Work cross functionally to determine department's training needs, and develop effective, modular based training (e.g. curriculums, Instructor Led Training, and On-the-Job training);
- Participate in implementation of "Smart" curriculums in LMS;
- Support departments in creating, implementing and maintaining site quizzes within LMS;
- Support management by creating and reporting key training metrics (e.g. Monthly and Quarterly Management reports, weekly overdue/coming due assessments);
- Support and participates in internal and external audits;
- Perform focused new hire and refresher training of current employees (performed individual, virtually and in group settings);
- All other duties as assignedThe Candidate
- Associate degree required. Bachelor's degree preferred;
- Minimum of three(3) years of relevant work or relevant comparable background required. Preferences to experience in the Biotechnology or Pharmaceutical industries;
- Must be proficient in MS Office Suite applications, ComplianceWire (LMS) and eDMS (Documentum);
- Strong organizational skills, oral and written communication skills, and attention to detail;
- Understanding of quality assurance concepts and practices specific to work within a regulated environment (e.g. Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP));
- Demonstrates emerging skills in influencing others and ability to develop innovative ideas for solving problems;
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;Why you should join Catalent:
|
 |
RSS Job Feeds