Associate, Quality Control Data Review
Company: Disability Solutions
Location: Indianapolis
Posted on: October 2, 2024
Job Description:
Working with UsChallenging. Meaningful. Life-changing. Those
aren't words that are usually associated with a job. But working at
Bristol Myers Squibb is anything but usual. Here, uniquely
interesting work happens every day, in every department. From
optimizing a production line to the latest breakthroughs in cell
therapy, this is work that transforms the lives of patients, and
the careers of those who do it. You'll get the chance to grow and
thrive through opportunities uncommon in scale and scope, alongside
high-achieving teams rich in diversity. Take your career farther
than you thought possible.Bristol Myers Squibb recognizes the
importance of balance and flexibility in our work environment. We
offer a wide variety of competitive benefits, services and programs
that provide our employees with the resources to pursue their
goals, both at work and in their personal lives. Read more:
.RayzeBio is a dynamic biotechnology company headquartered in San
Diego, CA. Launched in late 2020 and recently acquired by Bristol
Myers Squibb (BMS) as a wholly owned subsidiary, the company is
focused on improving survival of people with cancer by harnessing
the power of targeted radioisotopes. RayzeBio will operate as a
standalone entity within the BMS organization, maintaining its
biotech culture with the opportunity to leverage the best-in-class
oncology capabilities of BMS. RayzeBio is developing innovative
drugs against targets of solid tumors. The lead asset, RYZ101, is
in Phase 3 testing for patients with gastroenteropancreatic
neuroendocrine tumors (GEP-NETs), as well as earlier stage testing
for patients with small cell lung cancer (SCLC). Led by a
successful and experienced entrepreneurial team, RayzeBio aims to
be the global leader in radiopharmaceuticals. RayzeBio, a Bristol
Myers Squibb company, is seeking applicants for a Quality Control
Data Reviewer. We are seeking a detail-oriented Quality Control
Data Reviewer to play a key role in the development and
commercialization of RayzeBio's targeted alpha therapy (TAT)
radiopharmaceuticals. Ideally, the candidate will have prior
laboratory and technical experience in the radiopharmaceutical
industry. Additional responsibilities may include documenting
and/or conducting laboratory investigations.**This is an onsite
position located at Rayzebio's Indianapolis, IN site*Key
Responsibilities:
- Review Quality Control data for accuracy, completeness and
compliance with established procedures and regulatory
requirements.
- Ensure Quality Control data is reviewed in a timely
manner.
- Conduct periodic review and updates of Quality Control Standard
Operating Procedures, as necessary.
- Conduct Investigations-Lead and conduct in-depth investigations
following standard operating procedures for out of specification
results and other quality issues in the quality control
laboratory.
- Document Findings of investigations-write detailed
investigation reports and work with QA and QC management to propose
provide corrective action and corrective training to prevent repeat
events.
- Ensure data integrity throughout data review and investigations
as required.
- Proactively identify opportunities for improvements to both
investigations and the data review processes.
- Position is salaried position, generally first shift, but
extended hours or weekend work based on radiopharmaceutical
manufacturing schedule may be required
- This position will require the applicant to work with and
around ionizing radiation, biohazardous materials, and hazardous
chemicals.
- Up to 10% of travel may be required.
- Other duties as assigned by management.Education & Experience:
- BS in Chemistry, Biology, Science, or relevant field with five
to seven years of experience in pharmaceutical or other cGMP
experience. Advanced degrees may be acceptable with less
experience, however direct experience with cGMP technical writing
is required.
- Thorough understanding of cGMP regulations, ICH guidelines, FDA
and other regulatory process investigation process
- Experience with injectable pharmaceuticals or
radiopharmaceuticals strongly preferred.
- Experience tracking maintenance of laboratory equipment
preferred.Skills & Qualifications:
- Ability to multi-task, and prioritize work based on multiple
work-flows is a must
- Ability to handle hazardous materials safely
- Good organizational practices are required
- Strong analytical and problem-solving skills.
- Ability to work well and communicate effectively with multiple
stakeholders
- Strong written and oral communication skills
- Work with computer programs, including but not limited to
Microsoft Office
- Highly motivated with the ability to work independently,
without direction, or with others in a team environment#RayzebioIf
you come across a role that intrigues you but doesn't perfectly
line up with your resume, we encourage you to apply anyway. You
could be one step away from work that will transform your life and
career. Uniquely Interesting Work, Life-changing CareersWith a
single vision as inspiring as Transforming patients' lives through
science--- , every BMS employee plays an integral role in work that
goes far beyond ordinary. Each of us is empowered to apply our
individual talents and unique perspectives in an inclusive culture,
promoting diversity in clinical trials, while our shared values of
passion, innovation, urgency, accountability, inclusion and
integrity bring out the highest potential of each of our
colleagues.On-site Protocol BMS has a diverse occupancy structure
that determines where an employee is required to conduct their
work. This structure includes site-essential, site-by-design,
field-based and remote-by-design jobs. The occupancy type that you
are assigned is determined by the nature and responsibilities of
your role: Site-essential roles require 100% of shifts onsite at
your assigned facility. Site-by-design roles may be eligible for a
hybrid work model with at least 50% onsite at your assigned
facility. For these roles, onsite presence is considered an
essential job function and is critical to collaboration,
innovation, productivity, and a positive Company culture. For
field-based and remote-by-design roles the ability to physically
travel to visit customers, patients or business partners and to
attend meetings on behalf of BMS as directed is an essential job
function. BMS is dedicated to ensuring that people with
disabilities can excel through a transparent recruitment process,
reasonable workplace accommodations/adjustments and ongoing support
in their roles. Applicants can request a reasonable workplace
accommodation/adjustment prior to accepting a job offer. If you
require reasonable accommodations/adjustments in completing this
application, or in any part of the recruitment process, direct your
inquiries to . Visit to access our complete Equal Employment
Opportunity statement. BMS cares about your well-being and the
well-being of our staff, customers, patients, and communities. As a
result, the Company strongly recommends that all employees be fully
vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest
and conviction records, pursuant to applicable laws in your area.If
you live in or expect to work from Los Angeles County if hired for
this position, please visit this page for important additional
information: Any data processed in connection with role
applications will be treated in accordance with applicable data
privacy policies and regulations.
Keywords: Disability Solutions, Lafayette , Associate, Quality Control Data Review, Other , Indianapolis, Indiana
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