Specialist, QA Release (Mon-Fri, 1st Shift)
Company: Boehringer Ingelheim
Location: Saint Joseph
Posted on: September 8, 2019
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 BIVI, 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 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 &
- Documentation Review/Approvals\:
- Prepares batch record documentation and performs review for
compliance to Good Documentation Practices and against established
- Resolves minor issues found during documentation review
(documentation errors, missing information) as directed by
- 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.
- Change Control\:
- Performs review and approvals of change controls as a subject
matter expert (SME)in QA Release for routine change controls.
- Completes change control action items as assigned.
- Revises existing procedures as changes occur.
- Initiates deviations in Quality electronic systems when
non-conformances are detected during documentation review.
- Writes or participates in deviation investigations for
determination of appropriate root causes.
- Performs follow-up on CAPAs for completion.
- Performs movement transactions in SAP system of product as
- Performs usage decisions for batch release in SAP
- Performs second check in SAP prior to batch release.
- Actively participates on project teams as assigned by
- Coordinates and leads projects with supervision.
- Coordinates and leads projects within group without
- Completes all assigned training by target due dates as assigned
- 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.
- Performs 2nd review/release approval of serials/lots.
- Initiates non-conformance reports for serials/lots that do not
- Routinely reviews specifications/ standards/ inspection plans
for compliance to current regulatory requirements.
- Demonstrates understanding of regulations for various
- Participates in internal audits as assigned by management.
- Serves as an SME for strategy rooms during internal and
- Identifies, creates CAPAs and tracks them through to
- Bachelor?s Degree from an accredited institution in a relevant
scientific discipline plus two (2) years of relevant experience or
Master?s Degree from an accredited institution in a relevant
scientific discipline is required for this position.
- Ability to utilize computer programs such as Microsoft suite,
SAP,IDEA for CON, Learning One Source and other relevant electronic
applications is required?
- NOTE\:? Relevant BIVI experience may be weighted more
- Must be legally authorized to work in the United States without
- Must be willing to take a drug test and post-offer physical (if
- Must be 18 years of age or olderWho 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??
Visitboehringer-ingelheim.comand join us in our effort to make more
health.Boehringer Ingelheim, including Boehringer Ingelheim
Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer
Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal
Health Puerto Rico LLC, and Boehringer Ingelheim Fremont, Inc.?is
an equal opportunity and affirmative action employer committed to a
culturally diverse workforce.? All qualified applicants will
receive consideration for employment without regard to race; color;
creed; religion; national origin; age; ancestry; nationality;
marital, domestic partnership or civil union status; sex, gender
identity or expression; affectional or sexual orientation;
disability; veteran or military status, including protected veteran
status; domestic violence victim status; atypical cellular or blood
trait; genetic information (including the refusal to submit to
genetic testing) or any other characteristic protected by
Keywords: Boehringer Ingelheim, Saint Joseph , Specialist, QA Release (Mon-Fri, 1st Shift), Other , Saint Joseph, Missouri
Didn't find what you're looking for? Search again!