Specialist, Facilities Compliance (QA Investigator)
Company: Disability Solutions
Location: Severn
Posted on: September 28, 2024
Job Description:
The Facility Compliance Specialist will report to the Manager of
Facility Compliance. The role of the specialist is to provide
support for facility quality. Provide regulatory guidance and GMP
training to facilities and engineering team to maintain a high
level of quality.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:
- Ensure that all facility utilities preventive maintenance is
performed in accordance with cGMP guidelines.
- Generate SOP's, deviations, and change control as required for
related Facilities systems.
- Support compliance effort in facilities and engineering
ensuring group operates in accordance to Catalent's cGMP quality
system.
- Maintain departmental industry compliance in support of GMP
Manufacturing, Product Development administrative and laboratory
activities.
- Support client and regulatory audits, audit responses and
follow up corrective actions when required.
- Keep the leadership of Facilities and Engineering informed of
abnormal or critical situations and seek advice on matters outside
the specialist's knowledge or authority.
- Provide training on GMP compliance.The candidate:
- BS degree in a technical field or equivalent experience.
- 3 plus years of GXP quality system experience.
- Experience in cross functional teams in a fast-paced
environment.
- Good working knowledge of facilities equipment and O&M
requirements
- Understanding of GMP compliance for facilities.
- Strong understanding of proper OSHA safety practices and
proceduresWhy you should join Catalent:
- Competitive medical benefits and 401K
- 152 hours PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement ProcessesCatalent
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, Severn , Specialist, Facilities Compliance (QA Investigator), Other , Severn, Maryland
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