Quality Control Analyst II - Analytical
Company: Disability Solutions
Location: Chelsea
Posted on: September 22, 2024
Job Description:
Quality Control Analyst II 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 Control Analyst who is
responsible for executing QC testing and related analytical
activities supporting product development, release and stability.
This person conducts routine and non-routine chemical and physical
analyses of raw materials, in-process materials and drug products
according to standard operating procedures. The Quality Control
Analyst compiles data for documentation of test procedures that may
include stability program testing and formulation studies,
participates in the preparation of investigations, summaries and
reports, and reviews data obtained for compliance to specifications
and reports out-of-trend and/or out-of-specification results.This
is a full time, salaried role, The core hours are Monday - Friday
8:00AM - 4:30PMCatalent 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
- Performs analytical testing of spray dried powder using
relevant methodologies (i.e. Delivered Dose, Anderson Cascade
Impaction, Next Generation Impaction);
- Operates analytical instrumentation (i.e. HPLC, UPLC, GC,
UV-vis, FTIR, laser diffraction, KF);
- Statistically and critically analyzes data for trending and
reporting into regulatory filings;
- Participates in Laboratory and/or Quality Investigations;
- Monitors equipment and instrumentation used on a daily basis to
ensure proper operation and calibration.
- Participates in the construction and/or revision of SOPs;
- Assists in the writing and updating of analytical test
procedures, protocol, log books and checklists;
- Responsible for identifying and alerting a supervisor of issues
on instruments and/or test executions; makes initial
recommendations for possible solutions and/or corrective actions;
--
- All other duties as assignedThe Candidate
- Bachelor's Degree required. Preferably in Physical or Chemical
Sciences (life sciences) with a minimum of 2+ years of relevant
work experience required; ----
- 1+ years regulated GMP environment experience required;
- Experience in MDI/DPI analytical test methods (i.e. Andersen
Cascade Impactor and Emitted Dose techniques) preferred;
- Extensive experience with executing QC test methods, generating
associated data packages, auditing data packages generated by
others, troubleshooting instrumentation, trending data and
statistical analyses required;
- Demonstrated ability to lead and/or author investigations to
determine root causes of OOTs and/or OOSs according to cGMP
standards required;
- Ability to troubleshoot and repair analytical instrumentation
such as HPLCs and UPLCs preferred;
- Experience with analytical method development and validation
preferred;
- 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, Chelsea , Quality Control Analyst II - Analytical, Professions , Chelsea, Massachusetts
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