GMP Training Specialist - Quality Assurance
Company: Disability Solutions
Location: Chelsea
Posted on: October 30, 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 .
Keywords: Disability Solutions, East Providence , GMP Training Specialist - Quality Assurance, Other , Chelsea, Rhode Island
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