Boehringer Ingelheim SR Specialist, QA Release in ATHENS, Georgia
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.
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 review and approvals of packaging batch records, and release of finished biological product. This position is a second shift position. 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 may include every stage of manufacturing at Boehringer Ingelheim Animal Health USA Inc.
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.
• 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 testing with the Quality Control Department.
• 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.
• 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 Second ShiftPackaging QA Inspector:
· Product Inspection and Release:
• Conduct product inspection to ensure:
o Verification of lot number and expiration date applied to components
o Verification of correct version of components
o Verification of approval of release by USDA, CVB-IC
o Verification of inventory
• Perform system transactions in LIMs and Oracle for the final release of product
· Quality Assurance Support to Packaging:
• Conduct line clearance per procedure.
• Complete routine self inspections of the Packaging floor to ensure compliance with applicable procedures.
• 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.
- Reviews and approvesCertificates of Analysis and Certificates of Conformance for batchrelease.
Performs review and approvalsof change controls as a subject matter expert (SME) in QA Release forroutine change controls.
Performs review and approvalsof significant change controls (new facility/new equipment/new product).
Completes change control actionitems as assigned.
Revises existing procedures aschanges occur.
Creates new documents(SOPs/Forms/templates) as needed.
Initiates deviations in Qualityelectronic systems when non-conformances are detected during documentationreview.
Assesses reviews and approvesdeviations (dept approver) and assigns investigations as needed.
Writes or participates indeviation investigations for determination of appropriate root causes.
Serves as QA approver forinvestigations as needed.
Performs follow-up on CAPAs forcompletion.
Performs movement transactionsin ERP (Enterprise Resource Planning Software) system of product asneeded.
Performs usage decisions forbatch release in Oracle
- Actively participates onproject teams as assigned by manager
Completes all assigned trainingby target due dates as assigned by BI Animal Health Inc.
Completes on the job trainingfor each assigned job task.
Cross trains on other job taskswithin department.
Assists with training otherindividuals within the department on specific tasks.
Performs training otherindividuals within department per assigned training plans.
Assists QA management with thedevelopment of training plans within department and trains others.
Develops training plans andtrains others, including training outside of area of responsibility.
Routinely reviewsspecifications/ standards/ inspection plans for compliance to currentregulatory requirements.
Initiates new specificationswith SME/Manager input as needed for new materials.
Participates in internal auditsas assigned by management.
Identifies, creates CAPAs andtracks them through to completion.
Bachelor’s degree, from anaccredited institution, in a relevant scientific discipline plus five (5)years of relevant experience related to product or raw material /component inspection required NOTE : Relevant BoehringerIngelheim Animal Health USA Inc. experience may be weighted moresignificantly.
This position requires abilityto utilize computer programs such as Microsoft suite, Oracle/SAP, IDEA forCON, Learning One Source and other relevant electronic applications.
Strong focus on attention to details, accountability, agility, and Intrepreneurship.
Must be legally authorized towork in the United States without restriction.
Must be willing to take a drugtest and post-offer physical (if required)
Must be 18 years of age orolder
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc.. and Boehringer Ingelheim Fremont, Inc. is an equal opportunity employer. Minority/Female/Protected Veteran/Person with a Disability
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
Title: SR Specialist, QA Release
Requisition ID: 191843