Analytical Quality Assurance Associate
Company: Disability Solutions
Location: Morrisville
Posted on: April 19, 2024
Job Description:
Position Summary:Catalent Pharma Solutions is Morrisville, NC is
hiring a Analytical Quality Assurance Associate for the Analytical
group. The Analytical Quality Associate will perform routine
auditing of pharmaceutical projects, using established procedures,
and independently perform routine work with progressively more
involvement in recommendations for the improvement of the
departmentThis is a full-time position: Monday - Friday,
8:00AM-5:00PM.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 Research
Triangle Park (RTP) facility is Catalent's Center of Excellence for
Analytical Services and is also home to Catalent's Inhalation
franchise including product development, clinical and commercial
manufacturing for pMDI, DPI and Nasal Sprays.----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, approve, and issue certificates of analysis
- Review and approve Empower audit trail
- Perform project archival and pack-outs
- Follow GXP (e.g. GMP, GDP, etc.) as necessary to accomplish
daily tasks
- Participate in QA programs, procedures, and controls to ensure
that products conform to established standards and agency
guidelines
- Meet deadlines according to agreed timeframes and communicate
adjustments as needed
- Follow all Good Documentation Practices and cGMPs to ensure
compliance to applicable FDA guidelines and MHRA guidelines
- All other duties as assigned;The Candidate
- This position is entry level with a Bachelors in a related
field
- In lieu of a Bachelors degree we can accept relevant
experience
- Must be able to follow a variety of instructions furnished in
written, oral, diagram, or schedule form
- Microbiology experience is strongly preferred
- Strong written and verbal communication skills
- High level of organizational skills are required
- Working knowledge of cGMP, GLP, ICH, and USP regulations or
guidelines is strongly preferred
- Requires contact with multiple departments and on occasion with
customers
- 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--
- 152 hours of PTO + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- 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 bonus potential--
- Community engagement and green initiatives--
- Generous 401K match--and Paid Time Off accrual--
- Medical, dental and vision benefits effective day one of
employment--
- Tuition Reimbursement--- Let us help you finish your degree or
earn a new one!
- GymPass 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.--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, Cary , Analytical Quality Assurance Associate, Other , Morrisville, North Carolina
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