Quality Assurance Associate II - Manufacturing
Company: Disability Solutions
Location: San Diego
Posted on: May 2, 2024
Job Description:
Quality Assurance Associate II - Manufacturing Catalent Pharma
Solutions in San Diego is currently hiring a Manufacturing Quality
Assurance (MQA) Associate II who is responsible for a wide variety
of activities pertaining to supporting, maintaining, and assuring
compliance with quality systems requirements and applicable
regulatory requirements; to advance the development and manufacture
of drug candidates. This will include documentation review and
approval, dispositioning of product or its intermediates &
supporting manufacturing operations.This position is 1st shift
Monday-Friday from 8am-5pm.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.--Catalent Pharma Solutions in San Diego is a premier
pharmaceutical chemistry development and manufacturing organization
supporting the pharmaceutical and biotechnology industries. We
focus on bringing client drug compounds from discovery to the
clinic with services that include analytical development,
pre-formulation testing, formulation development, GMP manufacturing
and stability storage and testing as well as Clinical Supply
Services. --At Catalent San Diego, we recruit and develop
exceptional individuals with a passion for science and
determination to excel. We offer a technically challenging and
stimulating environment and the opportunity to learn from the
best.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:
- Reviews and dispositions production batch records for product
release. Determines if records are compliant with internal and cGMP
regulations;
- Liaison between Manufacturing and QA for executed Batch Record
Review and flow of documents;
- Liaison between QA and client, effectively communicates with
clients in regards of Executed Batch Records and review
status;
- Tracks status of EBR's and maintains established deadlines for
completion of review and corrections;
- Reviews and approves GMP product labels;
- Support GMP manufacturing activities including release of GMP
materials, shipment verification and performance of line clearances
in a Class 100,000 environment, maintenance of clinical trial
material inventory logs;
- Duties include but not limited to hosting client and regulatory
audits, Non-conformance and Environmental Monitoring review, Master
Batch Record review and approval, Deviation & Investigation review
and approvals, Occasional SOP revision and review, and Occasional
training of other QA personnel;
- Other duties as assignedThe Candidate:
- Bachelor's degree required, Chemistry or Biochemistry
preferred;
- Candidate will have 2+ years of work experience, preferable in
a GXP manufacturing environment or similar;
- Candidate must also be highly detail-oriented and organized,
able to work both independently and as a team player with a
positive attitude;
- All other duties as assignedPay:
- The annual pay range for this position in California is $55,000
- $65,000 annually. The final salary offered to a successful
candidate may vary, and will be dependent on several factors that
may include but are not limited to: the type and length of
experience within the job, type and length of experience within the
industry, skillset, education, business needs, etc.-- Catalent is a
multi-state employer, and this salary range may not reflect
positions that work in other states.Why you should join Catalent:
- Awesome employee activities:-- Movie Day, Monthly Birthday
Celebrations, Friday Bagel Breakfast, On-site Fitness Center with
machines, on-site yoga and HIIT classes, Sponsored Sports Teams,
and several other company-sponsored events that encourages positive
employee comradery, which contributes to effectively building
positive employee relationships, overall creating a positive work
environment.
- Environmentally friendly green initiatives with on-site
practices as well as regularly participating in Beach Clean-up
activities for community engagement.
- Defined career path and annual performance review and feedback
process. Potential for career growth on an expanding team within an
organization dedicated to preserving and bettering lives. --
- Several Employee Resource Groups focusing on Diversity and
Inclusion.
- Competitive salary with bonus potential. Generous 401K
match--and Paid Time Off accrual. Medical, dental and vision
benefits effective day one of employment.--
- 152 hours of PTO + 10 paid holidays.
- Positive and fast-paced working environment focusing on
continually improving processes to remain innovative and
dynamic.
- 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 categories.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, Corona , Quality Assurance Associate II - Manufacturing, Other , San Diego, California
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