The basic purpose of this position is to ensure the quality and compliance of raw materials received and released in Athens, Georgia. The position may require back-up for QA Inspectors in packaging. This position may require second shift work.
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:
* Raw Material Release:
* Perform incoming receipt on all raw materials including the following:
* Review of reception documents against specification to ensure specified part number received from approved supplier.
* Physical inspection of raw materials to ensure compliance with specified description.
* Review of CofA, CofI, CofO, etc., to ensure compliance with specifications.
* Coordinate raw material sample testing with the Quality Control Department or outside vendors.
* Perform material status changes including release and rejection in electronic inventory system to disposition lots of incoming raw materials.
* Update / create new raw material specifications as necessary to support new products or expansion of the raw material release system.
* Maintain the raw material release KPI.
* Conduct SOP and data capture updates for raw material release as required.
* Review raw material sections of OOPs and SOs on an annual basis for compliance and update as necessary.
* Perform date extensions on materials as required.
* Work with manufacturing to manage unused raw material destruction and disposal.
* Review manufacturing records and data capture forms to ensure compliance with applicable procedures and good documentation practices.
* Provide input on documentation revisions as necessary to ensure up to date / accurate procedures.
* Actively participates on project teams as assigned by manager
* Performs movement transactions in ERP (Enterprise Resource Planning Software) system of product as needed.
* Performs usage decisions for batch release in Oracle
* Management of Warehouses:
* Provide Quality Assurance support to the Warehouse departments as applicable.
* Review / Approve deviations, change controls, document revisions, etc. associated with the Warehouses/raw materials.
* Support Quality Third Party Manager with periodic material risk assessments and support other areas within the QA department as needed.
* Back-up Packaging QA Inspectors
* Perform packaging component issuance verification
* Conduct product inspection to ensure:
* Verification of expiration date and serial number applied to label
* Verification of correct version of label applied to product.
* Packaging documentation review and release
* Verification of approval of release by USDA, CVB-IC
* Verification of inventory at release.
* Perform system transactions in Oracle for the final release of product
* Perform line clearances of packaging equipment
* Conduct self-inspection audits (process, facility and documentation.
* Change Control:
* Performs review and approvals of change controls as a subject matter expert (SME) in Raw Material Release for routine change controls.
* Completes change control action items as assigned.
* Revises existing procedures as changes occur.
* Creates new documents (SOPs/Forms/templates) as needed.
* Initiates deviations in Quality electronic systems when non-conformances are detected during documentation review.
* Assesses reviews and approves deviations (dept 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.
* Completes all assigned training by target due dates as assigned by BI Animal Health Inc.
* 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.
* Participates in internal audits as assigned by management.
* Identifies, creates CAPAs and tracks them through to completion.
* Ensures routine raw material release aligns with regulatory compliance for USDA, FDA and other authorities, as applicable.
* Bachelors degree, from an accredited institution, in a relevant scientific discipline (Chemistry preferred) with a minimum two (2) years relevant experience related to raw material inspection and release.
* In lieu of a degree, a minimum of ten (10) years of relevant experience related to raw material inspection and release.
* Must have a good understanding of QA related to raw material release and vaccine packaging process.
* cGMP experience preferred.
* Computer skills preferred.
* Strong focus on time management, organization, attention to details, accountability, agility, and Intrepreneurship.
* Must be able to lift up to 35 pounds.
* Must be able to squat, bend, and stoop, as well as twisting and turning.
* Manual dexterity and visual acuity are important.
* Must be able to wear appropriate Personal Protective Equipment (PPE.)
* This position may require second shift and weekend work. Regular attendance is a must.
* Ability to work in a team environment or independently, interacting with all levels of management.
* 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 (https%5C://www.boehringer-ingelheim.us/covid-19) 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 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 persons 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.