Quality Assurance Specialist I
Company: Disability Solutions
Location: Chelsea
Posted on: May 3, 2024
Job Description:
We're hiring for a rotating night shift Quality Assurance
Specialist I to provide QA support for cGMP manufacturing
activities, at our facility in the Boston area!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 Quality Assurance Specialist I is responsible for
supporting the QA oversight of a GMP manufacturing facility. This
individual provides a real-time review of production activities.
This is a full-time, salary position and is 100% site-based. The
schedule is 6:00PM - 6:00AM and rotates from 48 hours of work in 4
days one week, to 36 hours of work in 3 days the following week
(every other weekend will have work scheduled.) --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 and--compliance, and to the
safety of every patient, consumer, and Catalent employee.--The
Role
- Review of production activities, including area clearance,
issuance, and review of batch records.
- Support of Environmental Monitoring program, including water
and other utilities sampling.
- Disposition of controlled raw materials and work in progress
materials.
- Provide basic support during compliance inspections conducted
by external sources (i.e. Health authorities).
- Support GMP manufacturing shifts as needed, including
participation in shift changes, and floor meetings with the
operators.
- Other duties as assigned.The Candidate,
- Bachelor's degree in Life Sciences required.
- Minimum of one year of progressive experience, in a GMP
environment, required.
- Minimum of one year of quality experience, in a GMP
environment, required.
- Experience working in a clean room environment preferred.Why
you should join Catalent
- Defined career path and annual performance review and feedback
process.
- Medical, dental and vision benefits effective on first day of
employment.
- Potential for career growth on an expanding team and
organization.
- 152 hours of paid time off annually plus 8 paid holidays.
- Community engagement and green initiatives.
- Competitive salary with bonus potential.
- Tuition reimbursement program.
- Diverse, inclusive culture.
- Generous 401K match.---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 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, Salem , Quality Assurance Specialist I, Other , Chelsea, Massachusetts
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