SR Specialist, Quality
US-Boehringer Ingelheim Animal Health
 Gainesville, GA

Description:

This

position has responsibility for key QA functions at the Gainesville and Raleigh

sites including but not limited to Change Control Quality System, Complaints

Quality System, Self-Inspection, Readiness Tool and Site Quality System

Review. This individual will manage all aspects of Change Control and

Complaints. They will conduct self-inspections and be

responsible for the associated reports and responses/CAPAs. They will work with the site to

compile/udpate the Inspection Readiness Tool and Site Quality System

Review. Ensuring compliance of the programs with applicable current

domestic and international regulations, guidelines, industry practice and

internal policies/procedures.

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:

  • Track and maintain Change Control Quality System in the
    respective electronic quality system. Lead Technical Change Review and
    Change Control Meetings. Follow up on overdue and those Change Controls
    that are coming due to maintain compliance and that they get closed out.
    Track KPI's tied to Change Management and provide updates to department
    management monthly. Attend Change Control project meetings and provide QA
    oversight for these Change Controls.
  • Manage Complaint Quality System
    • Ensure complaints are investigated with quality impact
      assessments. Conduct investigation to include batch record, retain,
      stability sample review etc and report summary conclusion and findings
      for every complaint. Manage reporting and trending of complaints and maintain
      KPI’s as required. Will ensure that all applicable SOP are maintained to
      ensure compliance to corporate procedures and all applicable regulations.
  • Self-Inspection Program
    • Actively works with Self Inspection program – ensure
      Self Inspections are executed per schedule; follow up on open action
      items/CAPAs to ensure full closure of Self Inspection and activities
  • Inspection Readiness Tool
    • Ensures inspection readiness tool is reviewed on
      defined frequency. Works with respective departments to obtain updates on
      a routine basis. Ensure CAPAs are defined for identified gaps and follows
      up on status of CAPAs to ensure closure by respective due dates.
  • Site Quality System Review
    • Ensure Site Quality System Review is completed
      annually. Collect and compile information from contributing
      areas/departments. Runs Site Quality System Review meeting. Ensures
      associated report is completed.
  • Quality Assurance Support
    • Performs other assigned duties & projects deemed
      appropriate within the position scope

**May not own or have contact with

other birds or poultry**

Requirements:

  • Bachelor's degree from an accredited institution in a
    science related field or four (4) years of Quality Assurance experience in
    Animal or Human Biologics or Pharmaceutical manufacturing
  • Performs all Company business in accordance with all
    regulations and Company policy and procedures. When violations are
    noted/observed they are to be immediately reported to management.
  • Demonstrate high ethical and professional standards with all
    business contacts in order to maintain BI’s reputation in the community.
  • 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.
  • Change Control and Complaints quality system.
  • Strong computer skills to include Microsoft suite (e.g.
    Outlook, Word, Excel).
  • Project and time management.
  • Communication and ability to teach, coach or assist site
    regarding various systems
  • Decision Making & Delivering Results
  • Understands regulations
  • Integrity/Ethics
  • Planning & Organizing/Quality Orientation
  • Analytical Thinking
  • Excellent oral and written communication skills
  • Attention to detail imperative
  • Organization skills along with ability to manage time and
    work with little supervision
  • Capability to train others
  • Ability to work cross-functionally and establish effective
    working relationships with other departments along with working independently,
    interacting with all levels of management
  • Proficiency with PCs and MS Office applications (i.e.
    Outlook, Word, Excel) required; familiarity with electronic inventory control
    system preferable
  • Familiar with USDA 9 CFR and cGMP Regulatory
    requirements
  • Knowledge of quality assurance processes/systems
  • Knowledge of and/or experience working in a regulated
    environment (e.g. USDA, FDA, etc.) is a plus

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, 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; citizenship status, marital, domestic partnership or civil union

status; gender, gender identity or expression; affectional or sexual

orientation; pregnancy, childbirth or related medical condition; physical or

psychiatric disability; veteran or military status; domestic violence victim

status; genetic information (including the refusal to submit to genetic

testing) or any other characteristic protected by applicable federal, state or

local law.