QA/RA Compliance Specialist
Company: Disability Solutions
Location: Saint Petersburg
Posted on: October 26, 2024
Job Description:
QA/RA Compliance SpecialistPosition SummarySt. Petersburg is our
primary soft gel development and manufacturing facility in North
America with capacity of 18 billion capsules per year. --Within the
Catalent network, we offer a broad range of integrated formulation
and analytical services to solve difficult development and
manufacturing challenges. 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 QA/RA
Compliance Specialist will facilitate the businesses of Catalent
Pharma Solutions - Pharma Softgel - St. Petersburg, FL and that of
its customers. This is done by ensuring that Catalent operates
within governmental regulations for its pharmaceutical chemistry,
manufacturing and controls areas, and by providing appropriate
chemical/regulatory knowledge and support. The QA/RA Compliance
Specialist will interact directly with manufacturing, engineering,
product development, technical services, validation, etc personnel
and is responsible for the quality/regulatory feedback loop to
those impacted areas. Also, this position will involve preparing
filings to support site registrations and permits as well as
regulatory submissions to the FDA, FL DBPR, and other worldwide
agencies as needed to support Customer filings under the direction
of the team Group lead and manager.The Role
- Coordinate, Track, and Trend Change Controls issued for the
facility. Ensuring change controls meet the initial requirements
for implementation and reviewing completed change controls to
ensure all actions have been appropriately completed.
- Provide initial regulatory impact assessment on all change
controls as required.
- Liaise with customers to ensure customer requirements are
satisfied.
- Preparation and submission of A/NDA submissions (initial,
amendments, supplements, annual reports, 15-day Alert Reports);
drug master files (initial, amendments, annual reports); plant/site
master files; licenses, permits, and registrations to meet FDA and
State requirements (especially Florida)
- Interact with Customers and gather information as needed to
support registration activities.
- Assist in the preparation of standard operating procedures
(SOPs) associated with job function; review and approve SOPs
requiring the regulatory function participation under direction of
the Group Leader.
- Assist in regulatory/health authority audits collecting
information as requested.
- Collaborates with Subject Matter Experts (SME)s, management and
supervisory personnel from applicable areas to resolve problems
affecting product quality; collaboration includes investigating and
CAPA initiation, following up on issues and a working jointly
towards resolution.
- All other duties as assigned. The Candidate
- Bachelor's Degree in Science or related field required
(Chemistry, Microbiology or Biology) with a minimum of 3 years
related experience in the pharmaceutical manufacturing
industry.
- Strong background working with Change Controls and management
of change control processes.
- Prior experience working with investigation writing, including
root cause analysis and report writing a must (prior experience
with preparing annual product reviews preferred).
- PathWise Certification preferred.
- Prior regulatory affairs, quality control or quality assurance
experience is a must.
- Working knowledge of US application regulations and cGMPs, and
FDA Guidance for both.
- Excellent organization skills and extreme attention to detail
are a must.
- Excellent oral and written communication skills.
- Motivated, self-started, team player.
- Able to reflect a strong quality work ethic.
- Proven ability to multi-task and demonstrate diplomatic
skills.
- Proficient (excellent) English verbal and written communication
skills to convey and receive ideas and instructions to/from others
within and outside the organization.
- Ability to effectively present information and respond to
questions from peers, management, suppliers and customers.
- Strong organizational, analytical, and investigative skills,
including ability to solve problems with minimal guidance, a
must.
- Proficient skills in Microsoft Office applications (Word,
Excel, PowerPoint, Access).
- Working knowledge of cGMPs and/or OSHA regulations
required.
- Ability to solve problems with little guidance. Ability to
identify most efficient method in order to achieve predetermined
objective. Ability to work effectively under pressure with
constantly changing priorities and deadlines. Individual may be
required to sit, stand, walk regularly and occasionally lift to 15
lbs; no lifting greater than 44.09 pounds without assistance.
Specific vision requirements include reading of written documents
and use of computer monitor screen frequently. Ability to work
extended hours or off-hours as required.Why You Should Join
Catalent--
- Competitive medical benefits and 401K--
- 152 hours of 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, North Fort Myers , QA/RA Compliance Specialist, Other , Saint Petersburg, Florida
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