Boehringer Ingelheim Vetmedica, inc.

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Senior Specialist/Specialist, QA Release

at Boehringer Ingelheim Vetmedica, inc.

Posted: 11/15/2018
Job Status: Full Time
Job Reference #: 1813907
Keywords: manufacturing

Job Description

Description:
 
The basic purpose of this position is review and approvals of batch records, government release documentation and release of starting materials, in process and finished biological product.  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 includes every stage of manufacturing in BIVI, including product received from 3rd Party contract manufacturing organizations (CMOs).  This individual will be a resource for related technical and compliance information within the Quality and Compliance unit.
 
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
  • Documentation Review/Approvals:
  • Prepares batch record documentation and performs review for compliance to Good Documentation Practices and against established SOPs/standards.
  • Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP.
  • Resolves major issues that are not defined by SOP.
  • Reviews and approves Certificates of Analysis and Certificates of Conformance for batch release.
  • Performs review and approvals of APHIS Form 2008s against applicable Outlines of Production for submission to the USDA for all serial releases.
  • Performs review and approvals of MBPS/CBRs/international permits for international releases.
  • Creates and revises export documentation as changes occur.
  • Change Control:
  • Performs review and approvals of change controls as a subject matter expert (SME) in QA Release for routine change controls.
  • Completes change control action items as assigned.
  • Revises existing procedures as changes occur.
  • Deviations/CAPA:
  • Initiates deviations in Quality electronic systems when non-conformances are detected during documentation review.
  • Writes or participates in deviation investigations for determination of appropriate root causes.
  • Performs follow-up on CAPAs for completion.
  • SAP:
  • Performs movement transactions in SAP system of product as needed.
  • Performs usage decisions for batch release in SAP
  • Performs second check in SAP prior to batch release.
  • Projects:
  • Actively participates on project teams as assigned by supervisor
  • Coordinates and leads projects with supervision.
  • Coordinates and leads projects within group without supervision.  
  • Training:
  • Completes all assigned training by target due dates as assigned by BIVI.
  • 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.
  • Inspection:
  • Performs 2nd review/release approval of serials/lots.
  • Initiates non-conformance reports for serials/lots that do not meet requirements.
  • Routinely reviews specifications/ standards/ inspection plans for compliance to current regulatory requirements.
  • Regulatory:
  • Demonstrates understanding of regulations for various countries.
  • Audits/Inspections:
  • Participates in internal audits as assigned by management.
  • Serves as an SME for strategy rooms during internal and external audits/inspections.
  • Identifies, creates CAPAs and tracks them through to completion.

Specialist Requirements:

  • Bachelor's degree, from an accredited institution, in a relevant scientific discipline plus two (2) years of relevant experience OR Master's degree, from an accredited institution, in a relevant scientific discipline is required for this position.
  • NOTE:  Relevant BIVI experience may be weighted more significantly.
  • This position requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source and other relevant electronic applications.
Senior Specialist Requirements:
  • Bachelor's degree, from an accredited institution, in a relevant scientific discipline plus five (5) years of relevant experience OR Master's degree, from an accredited institution, in a relevant scientific discipline plus three (3) years relevant experience OR PhD, from an accredited institution, in a relevant scientific discipline is required for this position.
  • NOTE:  Relevant BIVI experience may be weighted more significantly.
  • This position requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source and other relevant electronic applications. 

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
Our Culture:
 

Boehringer Ingelheim is one of the world'stop 20 pharmaceutical companies and operates globally with approximately 50,000employees.  Since our founding in 1885, the company has remainedfamily-owned and today we are committed to creating value through innovation inthree business areas including human pharmaceuticals, animal health andbiopharmaceutical contract manufacturing.  Since we are privately held, wehave the ability to take an innovative, long-term view.   Our focusis on scientific discoveries and the introduction of truly novel medicines thatimprove lives and provide valuable services and support to patients and theirfamilies.  Employees are challenged to take initiative and achieveoutstanding results. Ultimately, our culture and drive allows us to maintainone of the highest levels of excellence in our industry. We are also deeplycommitted to our communities and our employees create and engage in programsthat strengthen the neighborhoods where we live and work.  Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals,Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc.,Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equalopportunity and affirmative action employer committed to a culturally diverseworkforce.  All qualified applicants will receive consideration foremployment without regard to race; color; creed; religion; national origin;age; ancestry; nationality; marital, domestic partnership or civil union status;sex, gender identity or expression; affectional or sexual orientation;disability; veteran or military status, including protected veteran status;domestic violence victim status; atypical cellular or blood trait; geneticinformation (including the refusal to submit to genetic testing) or any othercharacteristic protected by law.

 

BoehringerIngelheim is firmly committed to ensuring a safe, healthy, productive andefficient work environment for our employees, partners and customers. As partof that commitment, Boehringer Ingelheim conducts pre-employment verificationsand drug screenings.