Master Associate/ Specialist, QA Disposition
Company: Boehringer Ingelheim
Posted on: July 23, 2021
Boehringer Ingelheim Fremont is the
rapidly growing US arm of Boehringer Ingelheim’s Biologics Business
Unit. We are a fully integrated biologics operation with over 500
scientist and specialists, covering cutting edge early- to late
stage CMC development, clinical and commercial drug substance and
drug product manufacturing, medical device assembly for combination
products and packaging operations.
We are continuing our rapid growth,
investing over $200m into the expansion of our capacity and
capabilities, and creating approximately 200 new
Driving this growth is an exciting
pipeline of multiple Boehringer Ingelheim novel biologic entities
(NBEs) and biosimilars, as well as, a growing diverse portfolio of
therapeutics we develop and manufacture for other leading pharma
and biotech companies. This includes multiple commercial product
launches planned over the next couple of years, for which we
can tap into Boehringer Ingelheim’s unique experience of having
brought 30+ biologics to market
Leveraging our diverse talent pool,
we are also driving technology and innovation globally, through
major investment and collaborations into next generation
manufacturing platforms and technologies, which may change how
biologics will be made in the
Whether we work on our own products,
help partners to bring their products to market or innovate new
technologies and approaches - Everything we do, we do to help
patients! #LI-MS1 *I-SF1
The person in this position is responsible for
performing batch coordination, compilation, and disposition for
internal BI products and client products. This role serves as
a disposition subject matter expert for disposition topics and is
responsible for executing site priorities, maintaining disposition
processes, and supporting process improvements to achieve company
goals and department objectives.
As an employee of Boehringer Ingelheim, you will
actively contribute to the discovery, development and delivery of
our products to our patients and customers. Our global presence
provides opportunity for all employees to collaborate
internationally, offering visibility and opportunity to directly
contribute to the companies' success. We realize that our strength
and competitive advantage lie with our people. We support our
employees in a number of ways to foster a healthy working
environment, meaningful work, diversity and inclusion, mobility,
networking and work-life balance. Our competitive compensation and
benefit programs reflect Boehringer Ingelheim's high regard for our
- Performs assigned batch disposition activities
(CoA, CofC, lot genealogy, deviation and Change Control queries,
etc.) in alignment with cGMP and global BI requirements for
clinical and commercial release.
- Identifies deviations throughout Disposition
operations; records and reports issues to appropriate parties;
recommends corrective action and follows up to ensure timely
- Makes recommendations on batch disposition based
on overall quality assessment of the batch. Must be able to present
rationales and defend disposition decisions to Sr. Disposition
- Provides batch metrics as applicable to defined
processes and site goals.
- Manages deviations, CAPAs, Change Controls as the
QA Contact when needed/assigned.
- Identifies and supports local process
improvements within the Quality Assurance
Bachelor’s degree, from
an accredited institution, in Biology or Chemistry is preferred (or
closely related degree with these core courses as the foundation)
plus two (2) to four (4) years of Quality Assurance
of a Bachelor's Degree, High School Diploma with a minimum of six
(6) to eight (8) years biopharmaceutical industry experience with
cGMPs in areas described in this profile.
independent judgment and decision making abilities
of relevant regulations and guidances. (ie. cGMPs, SOPs,
problem-detection and problem-resolution skills
to facilitate conflict resolution and negotiation
possess demonstrated organizational skills that have proven results
in the ability to be self-directed while managing multiple
possess excellent verbal and written communication skills; good
- Associate's degree from an accredited institution
plus five (5) years of Quality experience or equivalent in a cGMP
pharmaceutical manufacturing environment with positions of
increasing responsibility; Or
- Bachelor’s degree from an accredited institution
in Science (Chemistry, Biochemistry, Microbiology) from an
accredited institution required with three (3) years of relevant
- Strong experience in Quality systems such as
Batch Release, Deviations, Auditing or Change
- Experience and knowledge in biologics or
combination product manufacturing, quality oversight, and release
of clinical or commercial products.
- Ability to compile and review large amounts of
data, documents, and procedures with strong attention to detail and
to make accurate and sound decisions on batch
- Expertise in Standard Operating Procedures, Good
Manufacturing Practices, Food and Drug Administration, and other
national and international regulatory requirements related to
quality testing in a clinical and commercial
- Auditing (internal/supplier) experience in a cGMP
- Demonstrated influencing, relationship building,
and effective facilitation skills.
- Good communication skills with the ability to
build strong working relationships with management and
- Demonstrated ability to execute against the
strategic and tactical objectives provided by leadership both
within Quality and outside of the function.
- Overall understanding of Quality Assurance
- Ability to interpret and relate Quality standards
for implementation and review to functional
- Ability to work effectively on problems of
diverse scope, with analysis/evaluation of data.
- High level of personal motivation and initiative,
demonstrated innovation, and ability to work independently on
- Strong decision-making skills.
- Attention to detail, safety, quality, and
- Proficiency with MS Office products (specifically
Word, Outlook, PowerPoint and Excel).
- Experience in SAP, OpsLIMs and Trackwise a
- Must be legally authorized to work in the United
States without restriction.
- Must be willing to take a drug test and
post-offer physical (if required).
- Must be 18 years of age or
Who We Are\:
At Boehringer Ingelheim we create value through
innovation with one clear goal\: to improve the lives of patients.
We develop breakthrough therapies and innovative healthcare
solutions in areas of unmet medical need for both humans and
animals. As a family owned company we focus on long term
performance. We are powered by 50.000 employees globally who
nurture a diverse, collaborative and inclusive
culture. Learning and development for all employees is key
because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com
and join us in our effort to make more health.
Boehringer Ingelheim is an equal opportunity
global employer who takes pride in maintaining a diverse and
inclusive culture. We embrace diversity of perspectives and strive
for an inclusive environment, which benefits our employees,
patients and communities. All qualified applicants will receive
consideration for employment without regard to a person’s actual or
perceived race; color; creed; religion; national origin; age;
ancestry; citizenship status, marital status; gender, gender
identity or expression; sexual orientation, mental, physical or
intellectual disability, veteran status; pregnancy, childbirth or
related medical condition; genetic information (including the
refusal to submit to genetic testing) or any other class or
characteristic protected by applicable law.
Keywords: Boehringer Ingelheim, Fremont , Master Associate/ Specialist, QA Disposition, Other , Fremont, California
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