Sr. Quality Assurance Specialist - Compliance
Posted on: November 18, 2022
Catalent Pharma Solutions is hiring a Senior QA Compliance
Specialist who is responsible for both performing and supporting
audits and driving continuous improvement initiatives for a GMP
This is a full time, salaried role, Day Shift Rotating Weekends
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 is committed to a Patient First culture through excellence
in quality andcompliance, and to the safety of every patient,
consumer, and Catalent employee.
- 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.
- All 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).
- Experience in a GxP auditor role required.
- Excellent oral and written communication skills.
- 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
- Diverse, inclusive culture
- 19 days of PTO + 8 paid holidays
- Dynamic, fast-paced work environment
- 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
- Competitive salary with quarterly bonus potential
- Community engagement and green initiatives
- Generous 401K matchand Paid Time Off accrual
- Medical, dental and vision benefits effective day one of
- Tuition Reimbursement
- On-site fitness center and wellness programs
- GymPass program to promote overall physical wellness
- Perkspot - offers exclusive or private discounts from
approximately 900+ merchants in a wide array of categories
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 customers and 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 Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and
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
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 email@example.com for us
to investigate with local authorities.
Keywords: Catalent, Chelsea , Sr. Quality Assurance Specialist - Compliance, Other , Chelsea, Massachusetts
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