Master/Specialist/Senior Specialist, QC Lab General
Company: Boehringer Ingelheim
Location: Fremont
Posted on: July 31, 2022
Job Description:
Description:
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 jobs.
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
globally.
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
future.
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!
Description:
Employee assigned to QC functional or technical area in either
HPLC/CE, Potency testing (Bioassay and Binding assays), Residual
Impurities, Physicochemical/Drug Product, Raw Materials/Cleaning
validation/verification. Performs duties under limited supervision
and according to standard operating and QC procedures. Technical
and Quality lead for non-routine, new method transfer / validations
/ qualifications, verifications and technical assessments.
Responsible for quality and compliance activities including new
test methods, specs, plans, reports, forms, SOPs, etc. with no
previous experience within the department. Group representative on
equipment qualifications for new and novel technology. Team lead
responsible for the quality risk assessment, onboarding,
qualification and implementation of non-routine, new equipment
validation. Identifies and implements novel improvements and new
ways of thinking toward lab processes and compliance activities.
Cross functional project team lead responsible for complex QC
related compliance deliverables throughout the entire Quality
System (deviations, investigations, OOS and CAPAs and change
controls) with impact across multiple functional areas in the QC
department. Serves as a QC subject matter expert (SME) representing
the department during audits for critical processes with impact
across multiple functional areas in the QC department. Represents
team on global team initiatives and external facing client teams.
Project leader of non-routine, new initiatives with local cross
functional impact. Establishes training curricula and train others
as a SME. Establishes timelines, sets goals and implements strategy
for site wide QC projects.
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
employees.
Duties & Responsibilities:
- Technical and Quality lead for non-routine, new method
transfer/validations/qualifications, verifications and technical
assessments. Group representative on equipment qualifications for
new and novel technology. Team lead responsible for the quality
risk assessment, onboarding, qualification and implementation of
non-routine, new method equipment validation.
- Identifies and implements novel improvements and new ways of
thinking toward lab processes and compliance activities.
Responsible for quality and compliance activities including new
test methods, specs, plans, reports, forms, SOPs, etc. with no
previous experience within the department. Cross functional project
team lead responsible for complex QC related compliance
deliverables throughout the entire Quality System (deviations,
investigations, OOS and CAPAs and change controls) with impact
across multiple functional areas in the QC department. Serves as a
QC subject matter expert (SME) representing the department during
audits for critical processes with impact across multiple
functional areas in the QC department.
- Documents work according to cGMP and cGDP.
- Adheres to established regulations and follows cGMP established
by site.
- Reports abnormalities and deviations in a timely and accurate
manner.
- Adheres to safety standards and identifies unsafe situations /
habits and escalates appropriately.
- Represents team on global team initiatives and external facing
client teams. Project leader of non-routine, new initiatives with
local cross functional impact. Establishes timelines, sets goals
and implements strategy for site wide QC projects.
- Maintains own training within compliance and trains other
technicians and associates on operations upon completion of trainer
qualification. Conducts group trainings on complex topics and
scientific principles as needed. Establishes training curricula and
train others as a SME. Implements new training procedures and
drives continuous improvement. Improves cross training and coaches
others.
- Leads OOX and OOE investigations.
- Identifies protocol discrepancies and ensures they are properly
defined, assessed and appropriate root causes are put in
place.
- Responsible for technical review, interpretation, trending,
quality review and investigation of atypical results. Influences
and leads inter-departmental meetings with cross functional
managers to resolve issues and produce solutions.
- Manages deviation investigations as applicable and provides
product quality impact assessment.
- Leads complex deviation investigations as applicable and
provides product quality impact assessment.
- Responsible for training others. Master Associate Requirements:
- Bachelors degree from an accredited institution in a science or
engineering related field, with four (4) years of experience in
cGMP regulated industry or equivalent; Or
- Masters degree from an accredited institution in a science or
engineering related field, with one (1) years of experience in cGMP
regulated industry or equivalent.
- Proven experience with technical review, analysis and
interpretation of scientific data.
- Experience with computer-based systems and ideally experience
with process control systems.
- Previous experience authoring SOPs, methods, and/or work
instructions and document work in a written format applying
cGMP/GDP standards.
- Subject matter expert in performing analytical methodologies
within different scientific principles relevant to
Biopharmaceutical manufacturing. Specialist Requirements:
- BS/BA from an accredited institution in a science or
engineering related field, with four (4) years of work experience
in analytical testing in a GMP regulated industry or equivalent;
Or
- MS/MA from an accredited institution in a science or
engineering related field, with two (2) years of work experience in
Analytical testing in a GMP regulated industry or equivalent.
- Proven experience with technical review, analysis and
interpretation of scientific data.
- Experience with computer-based systems and ideally experience
with process control systems.
- Previous experience authoring SOPs, methods, and/or work
instructions.
- Experience interacting with auditors and regulators, clearly
understand subject matter and concisely communicate within areas of
subject matter expertise. Sr. Specialist Requirements:
- Bachelors Degree in a science or engineering related field from
an accredited institution, with six (6) years of experience in
analytical testing in a GMP regulated industry or equivalent;
Or
- Masters Degree in a science or engineering related field from
an accredited institution, with four (4) years of experience in
analytical testing in a GMP regulated industry or equivalent:
Or
- PhD in a science or engineering related field from an
accredited institution, with two (2) years of experience in
analytical testing in a GMP regulated industry or equivalent. PhD
preferred.
- Proven experience with technical review, analysis and
interpretation of scientific data.
- Experience with computer-based systems and ideally experience
with process control systems.
- Previous experience authoring SOPs, methods, and/or work
instructions.
- Experience providing oral and poster presentations on complex
technical problems to other scientific experts.
- Subject matter expert in performing analytical methodologies
within different scientific principles relevant to
Biopharmaceutical manufacturing...... click apply for full job
details
Keywords: Boehringer Ingelheim, Fremont , Master/Specialist/Senior Specialist, QC Lab General, Healthcare , Fremont, California
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