Quality Systems Specialist, Training
Company: Disability Solutions
Location: Chelsea
Posted on: October 17, 2024
Job Description:
Quality Systems Specialist - Training 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 .
Keywords: Disability Solutions, Lynn , Quality Systems Specialist, Training, Other , Chelsea, Massachusetts
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