Principal Specialist, Quality Assurance/Quality Control
Company: Boehringer Ingelheim Pharmaceuticals, Inc
Location: Gainesville
Posted on: January 27, 2023
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Job Description:
Description: The Principal Specialist of Quality Operations
provides real-time Quality Assurance support in Operations ensuring
compliance with USDA, EU regulatory requirements and BIAH
procedures. Spending at least 50% of time in production, triage and
investigate large-scale major deviations with potential for impact
to product quality and/or impact to multiple departments such as
facility or utility investigations.This role identifies and
implements CAPA to prevent recurrence and drive toward Right
First-Time compliance.The incumbent will coach, mentor and promote
Quality Culture to ensure GMPs are appropriately followed. 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:Provides Quality Control support focused on
compliance with USDA, EU regulatory requirements and BIAH
procedures, deviation prevention via right first-time manufacture
and documentation, periodic assessments to maintain a state of
audit readiness, real-time batch record review, 4-eye verification,
calculations, sample control and delivery.Influences as a technical
resource and departmental SME for Quality related questions or
topics including Regulatory, Corporate, and Site-specific
requirements.Performs full investigations of major events with
potential product quality impact for complex products manufactured
at BIAH to identify the root cause, impact assessment, and CAPA to
assess quality requirements for compliance with USDA, EU, FDA, or
other GMP regulatory requirements and proposes disposition of the
product.Investigates large-scale deviations potentially impacting
multiple departments such as facility or utility
investigations.Triages real-time quality impact of events in
conjunction with shop-floor employees in support of deviation
management.Ensures impacted material is appropriately quarantined
and management notified.Supports Deviation Risk Assessment.Performs
operations related investigational activities as assigned in
TrackWise child Investigation records in support of High-risk
deviations / complaints.Performs review and approval of CAPAs
associated with the focus area.Conducts internal audits of
facility, production floor, equipment, and warehouse and provide
written reports summarizing findings.Builds understanding and
responsibility for area(s) of focus.Provides QC assessment and
approval for Change Controls.Leads major projects and implements
improvements in manufacturing procedures or processes as they
relate to inspection readiness and Right First Time (RFT)
compliance.Supports Quality Management activities (e.g., metrics,
strategic initiatives, Quality Risk Management (QRM) assessments,
Change Control assessment, Change Control closure).Performs
trending and analysis of deviations and works with responsible area
owners to identify opportunities for improvement.Supports during
Regulatory / corporate audits including contributions to strategies
to successfully respond to auditor concerns.Leads alignment of
quality assurance events with functions across different areas
within production (Central Services, Cells / Media Production,
Active Ingredient Production, Formulation / Filling / Freeze Drying
/ Capping Production, and Quality Control Testing).Requirements: A
Bachelor's degree in a relevant scientific discipline plus 8 years
relevant experienceORMaster's degree in a relevant scientific
discipline plus 5 years relevant experienceORPhD in a relevant
scientific discipline plus 3 years relevant experience is
required.Must be able to manage and actively drive multiple
investigations and projects at varying stages of completion to meet
respective due dates.Demonstrates and influences understanding of
GMPs, root cause analysis, compliance requirements, and regulatory
requirements to assess product, procedures, recommended
improvements to make quality decisions.Demonstrating advanced
technical writing skills to provide complete, timely investigation
reports.Demonstrating logical skills with excellence in written and
verbal communication skills.Demonstrating advanced theoretical and
practical knowledge of regulated processes and technical
disciplines such as sterilization, aseptic processing, QC testing,
quality and compliance, production excellence, and/or maintenance
services.Able to select, develop, and assess the appropriateness of
regulated processes and technical disciplines associated with the
manufacture, testing, and verification of products manufactured by
BIAH.Demonstrating ability to lead and influence large projects and
teams.Organizational skills, and ability to manage tasks based on
experience leading projects.Ability to communicate clearly and
professionally, both verbally and in writing. Well-developed
interpersonal skills, with the ability to establish highly
functional relationships with diverse personalities both within and
outside the company. Solid knowledge of Good Manufacturing Practice
and international regulations. Ability to independently make sound
decisions and manage priorities in alignment with department and
site drivers.Ability to make and influence decisions with minimal
supervision regarding the acceptability of product based on
investigation provided.Previous experience in a leadership role
preferred.Attention to detail and commitment to customer
service.Technically self-sufficient and proficient in the
performance of investigations including root cause analysis, impact
assessment, CAPA development, and effectiveness of CAPA
plans.Excellent attention to detail.Requires ability to utilize
computer programs such as Microsoft suite, SAP, IDEA for CON,
Learning One Source, TrackWise and other relevant electronic
applications.NOTE:Relevant BIAH experience may be weighted more
significantly.Physical Demands / Surroundings: Lifting, pushing,
and pulling and/or carrying Constant periods of sitting.Frequent
standing, walking, or climbing stairs.Crouching/squatting,
bending/stooping, twisting, above the shoulder or low-level work,
fine finger dexterity/ including grasping required
occasionally.Writing and typing constantly.Visual / Hearing
Demands: Color vision required.May require extended hours at a
computer screen. Must be able to read electronic documents of all
types.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 Pharmaceuticals, Inc, Atlanta , Principal Specialist, Quality Assurance/Quality Control, Other , Gainesville, Georgia
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