Specialist, Quality Assurance
Company: Disability Solutions
Location: Princeton
Posted on: April 19, 2024
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Job Description:
POSITION SUMMARYCatalent 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
Specialist, Quality Assurance provides Quality Assurance support
for GMP Raw Materials that support the production of GMP
Manufacturing operations of cell therapy products at our US Cell
Therapy facility located in Princeton, NJ. Responsibilities include
providing QA oversight of materials used for Manufacturing, Quality
Control, and Process & Analytical Development. Executing assigned
quality tasks (including pre-approving instructions, reviewing
documentation of executed instructions, --reporting metrics,
document drafting, report writing), providing review and approval
of change requests (e.g., Trackwise change controls and EDMS
document change requests), approving GxP deliverables, product
specifications, --reviewing and approving deviations, corrective
and preventive actions, risk assessments, and reviewing resolution
and effectiveness of corrective actions, and audit responses.
Continuously monitor systems and procedures to ensure compliance
with applicable regulatory and industry standards, quality
improvements, and efficiency for phase appropriate GMP manufacture
of biological products.--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:------- --Conducts critical reviews of GMP documentation
associated with materials control (material specifications, receipt
inspection forms, inventory records, item request form) by
exercising judgement within defined procedures and
regulations.--------- --Performs line clearance and QA on the floor
activities; Review and dispositions batch records; Works with
Materials Control to quarantine and disposition all GMP materials
in a timely manner; Review and approve Deviations/Change
Controls/CAPAs; Scanning and ancillary filing.------- --Assists
with the generation and/or revision of GMP documentation such as
Standard Operating Procedures as it pertains to the disposition of
Raw Materials.------- --Support regulatory and client
audit/inspections and supports internal audits of GMP systems and
facilities.------- --Works cross-functionally with Materials
Control, Purchasing, Manufacturing, Quality Control and other
departments to resolve raw material quality issues and provide
assistance when needed; Continually evaluates Quality and Materials
Control processes and procedures to improve efficiency and ensure
compliance to appropriate GMPs.------- --Collaborates with other
members of Quality Assurance, including cross training where
necessary, for performing duties and tasks in support of Catalent's
Quality Systems; Performs Acceptable Quality Limit (AQL) visual
inspection materials, as needed.------- --Other duties as
assigned.The Candidate:------- --Bachelor of Science degree is
required, Life Sciences discipline preferred------- --5+ years'
experience within the biologic, biopharmaceutical, or regulated
industry; 3+ years' experience in Manufacturing/Quality
Assurance/Quality Control function preferred------- --Have the
knowledge, and ability to apply basic scientific and regulatory
principles utilized to solve operational, as well as routine
quality tasks------- --Strong knowledge base with Good
Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological
regulations per 21 CFR Parts 600s, ICH Guidelines and EU
GMPs.------- --Knowledgeable and/or exposure to aseptic
manufacturing processes including microbial and cell culture, and
fill/finish; Raw Materials experience is a plus------- --Creative
individual with excellent trouble shooting and decision-making
skills; Ability to quickly learn new and novel manufacturing
processes supporting new clients; Able to work in a team setting
and independently under minimum supervision; Requires the ability
to produce results in a fast-paced environment to meet client
deadlines; Able to effectively interpret new and existing global
regulations; Able to communicate effectively with all levels of
personnel and regulatory inspectors------- --Experience or
knowledge in Trackwise preferred------- --This candidate will be
required to support operations that may occur seven days a week.Why
you should join Catalent:------- --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--------- --Dynamic, fast-paced
work environment------- --Generous 401K match and Paid Time Off
accrual--------- --Medical, dental and vision benefits effective
day one of employment--------- --19 days of PTO + 8 paid
holidays------- --Tuition Reimbursement--------- --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, Levittown , Specialist, Quality Assurance, Other , Princeton, Pennsylvania
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