Specialist / Senior Specialist, Quality Assurance (QA) Release
Company: Boehringer Ingelheim
Location: Saint Joseph
Posted on: September 14, 2021
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Job Description:
Description: Description\:
The basic
purpose of this position is review and approvals of batch records,
government release documentation and release of starting materials,
in process and finished biological product. This position
assures that all specifications are met prior to each stage of
release to comply with USDA, FDA and cGMP regulatory requirements
relating to these areas. The scope of support includes every
stage of manufacturing in BIAH, including product received from 3rd
Party contract manufacturing organizations (CMOs). This
individual will be a resource for related technical and compliance
information within the Quality and Compliance unit, as well as
serve as a backup for the QA Release Group/Team Leader in the event
of their absence. 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\:
Documentation
Review/Approvals\: Prepares
batch record documentation and performs review for compliance to
Good Documentation Practices and against established
SOPs/standards. Resolves
minor issues found during documentation review (documentation
errors, missing information) as directed by SOP. Resolves
major issues that are not defined by SOP. Reviews
and approves Certificates of Analysis and Certificates of
Conformance for batch release. Performs
review and approvals of APHIS Form 2008s against applicable
Outlines of Production for submission to the USDA for all serial
releases. Performs
review and approvals of MBPS/CBRs/international permits for
international releases. Creates
and revises export documentation as changes occur. Performs
documentation review of media fills and media fill protocol
approvals as needed. Change Control\: Performs
review and approvals of change controls as a subject matter expert
(SME) in QA Release for routine change controls. Performs
review and approvals of significant change controls (new
facility/new equipment/new product). Completes
change control action items as assigned. Revises
existing procedures as changes occur. Creates
new documents (SOPs/Forms/templates) as needed. Deviations/CAPA\: Initiates
deviations in Quality electronic systems when non-conformances are
detected during documentation review. Assesses,
reviews and approves deviations (department approver) and assigns
investigations as needed. Writes or
participates in deviation investigations for determination of
appropriate root causes. Serves as
QA approver for investigations as needed. Performs
follow-up on CAPAs for completion. SAP\: Performs
movement transactions in SAP system of product as
needed. Performs
usage decisions for batch release in SAP Performs
second check in SAP prior to batch release. Performs
assessment and approvals of requests for items that are returned to
stock. Projects\: Actively
participates on project teams as assigned by supervisor Coordinates and leads
projects within group without supervision. Training\: Completes
all assigned training by target due dates as assigned by
BIAH. Completes
on the job training for each assigned job task. Cross
trains on other job tasks within department. Assists
with training other individuals within the department on specific
tasks. Performs
training other individuals within department per assigned training
plans. Assists
QA management with the development of training plans within
department and trains others. Develops
training plans and trains others, including training outside of
area of responsibility. Inspection\: Performs
2nd review/release approval of serials/lots. Initiates
non-conformance reports for serials/lots that do not meet
requirements. Routinely
reviews specifications/ standards/ inspection plans for compliance
to current regulatory requirements. Initiates new
specifications with supervisor input as needed for new
materials. Regulatory\: Demonstrates
understanding of regulations for various countries. Routinely
reviews regulatory correspondence/audit reports and assures
compliance of QA Release procedures. Provides
input into regulatory filings (OOPs/dossiers). Actively
participates in external groups (PTEA, AHI) Audits/Inspections\: Participates in internal
audits as assigned by management. Participates in 3rd
party audits as assigned by management. Serves as
an SME for strategy rooms during internal and external
audits/inspections. Identifies, creates
CAPAs and tracks them through to completion.
Candidate will be hired in at the level based on
education, experience and/or business need.
Senior Specialist
Requirements\: BS degree
from an accredited institution in a relevant scientific discipline,
plus five (5) years of relevant experience; Or MS degree from an
accredited institution in a relevant scientific discipline, plus
three (3) years relevant experience; or PhD from an accredited
institution in a relevant scientific discipline is required for
this position. NOTE\: Relevant
BIAH experience may be weighted more significantly. Requires
ability to utilize computer programs such as Microsoft suite, SAP,
IDEA for CON, Learning One Source and other relevant electronic
applications. Exceptional logical
skills with excellence in written and verbal communication
skills. Excellence in
comprehension/application of USDA and EU regulatory requirements
for production and distribution of regulated biological
articles. Strong
theoretical and practical knowledge of regulated processes and one
technical discipline, such as biology to apply knowledge or
experience to assigned tasks. Ability
to make decisions with minimal supervision regarding the
acceptability of product based on documentation
provided. Excellent
attention to detail.
Specialist Requirements\: Eligibility
Requirements\:
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 older
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, including natural
hairstyles, hair texture and protective hairstyles; 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, Saint Joseph , Specialist / Senior Specialist, Quality Assurance (QA) Release, Other , Saint Joseph, Missouri
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