Quality Assurance Specialist II
Company: Disability Solutions
Location: Chelsea
Posted on: October 29, 2024
Job Description:
Quality Assurance Specialist II - Night Position
Summary: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 Pharma Solutions is hiring a Quality
Assurance Specialist II - Operations who is responsible for
supporting operations in a GMP Manufacturing Facility. This
individual provides oversight of production activities with limited
supervision.This is a full time, salaried role. Work schedule will
be a rotating 12-hour schedule 6:00 p.m. to 6:00 a.m.-- Week 1 will
be 48 hours over 4 days, and week two will be 36 hours over 3
days.-- Overtime and Holiday pay will be included.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
- Oversight (with limited supervision) of production activities,
including area clearance, issuance and review of batch records, and
making decisions on initiation of Discrepancies;
- Oversight (with limited supervision), review, and approval of
Materials Management and Supply Chain activities;
- Support of Environmental Monitoring Program for Chelsea
Facility, including Controlled Environments and Clean
Utilities;
- Revision and/or review and approval of SOPs, Protocols,
Reports, and Master Batch Records for continuous improvement;
- Initiation of Discrepancies, including Deviations and
Investigations;
- Support of implementation of CAPA 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 basic support during compliance inspections conducted
by external sources (i.e. health authorities);
- Support GMP manufacturing shifts as needed, including
participation in shift change/floor meetings with the
operators;
- All other duties as assignedThe Candidate
- Bachelor's degree required, preferably in a scientific
discipline;
- Three (3) years of progressive experience in a GMP environment
required;
- Minimum of One (1) year of Quality Assurance experience in
support of GMP production required;
- Working knowledge of GMPs and their application to
pharmaceutical manufacturing required;
- Previous exposure to investigations and product complaints
preferred;
- Must be able to interpret applicable standards and objectively
make decisions with support of management;
- Experience in the use of Material Requirements Planning (MRP)
systems preferred;
- Excellent verbal 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
process--
- Diverse, inclusive culture--
- 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--
- 152 Hours + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic, fast-paced work environment
- Community engagement and green initiatives--
- Generous 401K match--
- Company match on donations to organizations
- Medical, dental and vision benefits effective day one of
employment--
- Tuition Reimbursement--- Let us help you finish your degree or
start a new degree!
- WellHub program to promote overall physical wellness--
- Perkspot - offers exclusive or private discounts from
approximately 900+ merchants in a wide array of categoriesCatalent
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, Waltham , Quality Assurance Specialist II, Other , Chelsea, Massachusetts
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