Veterans Preferred - Sr. QA Specialist
Posted on: November 17, 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
The Senior Quality Assurance Specialist - Operations is responsible
for supporting operations in a GMP Manufacturing Facility.
This position will be based at our Chelsea, MA facility. 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.
Members of our Quality team are vital to ensuring our products,
which include some of the latest life-saving medicines and the most
well-known consumer health brands are reliably supplied so that the
people can live better, healthier lives
- Oversight of production activities, including area clearance,
issuance and review of batch records, and making decisions on
initiation of Discrepancies
- Oversight, review, and approval of Materials Management and
Supply Chain activities
- Support of Environmental Monitoring Program for Chelsea
Facility, including Controlled Environments and Clean
- Reporting on the state of control of the Controlled Environment
and Clean Utilities for the Chelsea Manufacturing Site
- Reporting on Quality Metrics for production related events
- Revision and/or review and approval of SOPs, Protocols,
Reports, and Master Batch Records for continuous improvement
- Initiation, review, and approval of Discrepancies, including
Deviations and Investigations.
- Support of implementation of CAPA and review of CAPA
effectiveness as determined through Discrepancies
- Review and approval of Certificates of Analysis for Raw
Materials, Intermediates, and Finished Goods
- Disposition of controlled materials (Work in Progress, Finished
Product, and Raw Materials)
- Provide support during compliance inspections conducted by
external sources (i.e. health authorities)
- Active member of a self-directed work team with operations
personnel to critically evaluate and continuously improve
manufacturing control systems
- Support GMP manufacturing shifts as needed, including
participation in shift change/floor meetings with the
- Other duties may be assigned.
- Bachelor's degree in a scientific discipline is required,
preferably in physical Science or Chemistry.
- Minimum of 5+ years of progressive experience in a GMP
- Minimum of 5+ years of Quality Assurance experience in support
of GMP production.
- Must be proficient in MS Office Suite.
- Experience in the use of Material Requirements Planning (MRP)
- Excellent verbal and written communication skills.
- Ability to manage both day-to-day operations as well as project
work in a fast-paced environment.
- Ability to work both independently and in a collaborative team
- Ability to accept multiple tasks and adjust priorities, as
- Physical requirements: combination of office work and time
spent in the manufacturing facility.
Why you should join Catalent:
- Competitive medical benefits and 401K
- 19 days of PTO + 8 paid holidays
- Fast-paced, dynamic work environment
- Site is rapidly growing and expanding
- Conveniently located next to the train, parking available
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 email@example.com for us
to investigate with local authorities.
Keywords: Catalent, Chelsea , Veterans Preferred - Sr. QA Specialist, Other , Chelsea, Massachusetts
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