Principal Specialist, Packaging Training and Compliance
Company: Boehringer Ingelheim
Location: Hull
Posted on: August 6, 2022
Job Description:
Description:
Description:
The Principal Specialist, Packaging Training & Compliance will lead
the Packaging (PKG) documentation team to support the production
line as required through batch documentation review, deviations,
change controls, CAPAs, and document creation / revision in
compliance with procedures and regulatory requirements.
This role develops, reviews, and maintains an up-to-date training
program to meet all compliance requirements and packaging
requirements. The incumbent will maintain supplemental training
records and ensures all personnel are up to date on all compliance
requirements. Primary means of tracking training will be through
LOS System. On the Job Training (OJT) will tracked separately
outside of LOS. This role implements effective CAPAs to mitigate
potential issues in deviations and audits.
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 several 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:
- Acts as PKG internal SME for routine production issues leading
towards deviations, product dispositions, and response corrections
needed to continue production.
- Works directly with upstream and downstream processes to ensure
all documentation and trending issues impacting PKG Department are
addressed to mitigate production downtime.
- Works directly with PKG Team Leaders to ensure all shifts are
working in compliance with Packaging
guidelines/specifications.
- Supervises the timely execution and completion of CAPAs,
Investigations, Deviations, TPC, & Change Controls assigned to PKG
Leadership.
- Works with Packaging Management to properly document any
additional training outside of the LOS including On The Job (OJT)
Training and sign-off to ensure successful ownership of training
material.
- Performs all Company business in accordance with all
regulations (e.g., EEO, USDA, EU, EMA etc.) and Company policies
and procedures.
- Immediately reports noted/observed violations to
management.
- Leads alignment of release functions across different areas
within production and maintains/develops PKG Training Program.
- Interfaces with site management, Regulatory Affairs, production
area managers and supervisors to ensure release and support
functions are consistent and within regulatory requirements.
- Responsible for maintaining the training of PKG personnel to
meet regulatory requirements.
- Position directly impacts the production process and the
ability to get product produced RFT (right the first time).
- Directly supervises up to 2 direct reports.
- Responsible for ensuring compliance of all documentation.
Supervisor areas:
- Leads PKG document specialist through daily operations.
- Conducts or assists with performance evaluations and
development discussions.
- Leads a team of QA professionals through daily operations.
- As requested by the manager conducts or assist with performance
evaluations and development discussions. Product Release:
- Oversees the review / approval of manufacturing records,
deviations, product holds / dispositions, change controls, CAPAs,
document creation / revision, etc. as needed to release product
according to applicable procedures. Requirements:
- Bachelor s degree, from an accredited institution, in a
relevant scientific discipline.
- In addition to Bachelor's degree, minimum five (5) years
related experience and/or training in a Manufacturing environment
in Quality Assurance, Quality Control, Sterility Assurance,
Engineering, Production, or Qualification / Validation.
- Ten (10) years relevant experience in lieu of degree.
- Must have appropriate knowledge and good understanding of
quality activities related to pharmaceutical manufacturing process;
examples include product release, batch record review, root cause
analysis, change control.
- Must have appropriate knowledge and good understanding of
training activities related to pharmaceutical manufacturing
process.
- Functional knowledge of product manufacturing activities is
required.
- Functional knowledge of USDA requirements for biologic
production is recommended.
- Demonstrated high ethical and professional standards with all
business contacts to maintain BIAH excellent reputation in the
community. Preferred:
- Experience must be inclusive of three (3) years leadership
experience.
- Experience with Packaging, Labeling, bioreactors, parenteral
filling lines, freeze dryers.
- Experience with licensed biopharmaceutical or biological
products.
- Experience with aspects of sterility assurance (i.e.,
environmental monitoring, aseptic process simulations or media
fills, water systems, aseptic technique, etc.)
- Experience in an FDA and/or USDA or other regulated
industry.
- Fully versed in GMP s, FDA, USDA, European and other regulatory
agency requirements sufficient to comply to quality operations and
compliance.
- Training and experience in root cause analysis tools.
- Computer skills in Microsoft Office applications and the
ability to learn new applications quickly and easily. 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.
- This position will require individuals to be fully vaccinated
against COVID-19 or have an approved medical or religious
accommodation. Click here for more information on the vaccine
mandate and COVID-19. 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 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, Athens , Principal Specialist, Packaging Training and Compliance, Other , Hull, Georgia
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