Veterans Preferred - Sr. Quality Assurance Specialist - Compliance
Posted on: November 13, 2021
Military Veterans are Encouraged to Apply. Job Description
Catalent hires people with a passion to make a difference to the
health of millions of people globally. Your expertise, coupled with
Catalent's advanced technologies and collaboration with thousands
of innovative pharmaceutical, biotech and healthcare companies,
will help bring life-enhancing products to the people you know and
love. Your talents, ideas and passion are essential to our mission;
to develop, manufacture and supply products that help people live
better, healthier lives. Interested in learning more about life at
Catalent? Start here
Sr. QA Specialist - Compliance
The Sr. QA Compliance Specialist is responsible for both performing
and supporting audits and driving continuous improvement
initiatives for a GMP Manufacturing Facility.
This position is based out of our Chelsea, MA site.
- Performs Internal Audits across the various departments at the
site, which includes conducting audits, tracking actions to
closure, and writing reports.
- Supports Supplier Quality Management.
- Drives continuous improvement projects at the site, including
collaboration with project sponsors and subject matter
- Supports Data Integrity/Part 11 initiatives driven by the
global DIARP team.
- Performs and/or collaborates on Risk Assessments as needed for
new molecule onboarding and other projects.
- Supports implementation of electronic Quality Systems at the
- Supports FDA and EU medical device requirement assessments as
needed for onboarding of new clients.
- Hosts and/or supports client and Health Authority
- Generates metrics and trend reports in support of management
review & other QS initiatives, as necessary.
- May participate in internal cross functional project driven
- Other duties as assigned
- Bachelor's degree preferred.
- Minimum of five years of relevant work experience in the
Biotechnology or Pharmaceutical industries or relevant comparable
GMP background required.
- Demonstrates working knowledge of applicable regulations and
the interpretation and application of regulations and compliance
concepts (e.g. 21 CFR Parts 11, 210, 211, 820).
- Must be proficient in MS Office Suite.
- Knowledge of electronic quality systems such as Trackwise
- Excellent oral and written communication skills.
- Exhibits strong attention to detail.
- Demonstrates risk-based thinking & application in day-to-to
quality systems leadership decisions.
- Ability to manage both day-to-day operations as well as project
work in a fast paced environment.
- Demonstrates emerging skills in influencing others within
project teams regarding quality or compliance concerns.
Why you should join Catalent:
- Competitive medical benefits and 401K
- 19 days of PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
Catalent 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.
Catalent is committed to the health and safety of its employees,
visitors and the customersand patients we serve. As a result of the
global pandemic, we have modified many of our recruitment and
on-boarding processes to maintain everyone's safety. The Human
Resources teams will communicate all necessary safety processes and
procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.
Visit www.catalent.com/careers to explore career opportunities.
C atalent is an Equal Opportunity / Affirmative Action employer.
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, national origin,
disability, protected veteran status, sexual orientation or gender
identity. 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 DisabilityAccommodations@catalent.com . 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 firstname.lastname@example.org for us
to investigate with local authorities.
Keywords: Catalent, Chelsea , Veterans Preferred - Sr. Quality Assurance Specialist - Compliance, Other , Chelsea, Massachusetts
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