GMP Training Specialist - Quality Assurance

Company: Disability Solutions
Location: Chelsea
Posted on: November 15, 2024

Job Description:

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:
    • 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 + 8 paid holidays
    • Several Employee Resource Groups focusing on D&I
    • Dynamic, fast-paced work environment
    • Community engagement and green initiatives--
    • Generous 401K match--
    • Company match on donations to organizations
    • Medical, dental and vision benefits effective day one of employment--
    • Tuition Reimbursement--- Let us help you finish your degree or start a new degree!
    • WellHub program to promote overall physical wellness--
    • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categoriesCatalent 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 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 . 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 spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

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