Job 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 BIAH, 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 BIAH.
* 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.
Requirements:
* Bachelor;s degree from an accredited institution in a relevant scientific discipline, plus two (2) years of relevant experience required; or Master's degree from an accredited institution in a relevant scientific discipline
* NOTE: Relevant BIAH experience may be weighted more significantly.
* Requires ability to utilize computer programs such as Microsoft suite, SAP,IDEA for CON, Learning One Source and other relevant electronic applications.
* Exceptional logical skills with excellence in written and verbal communication skills.
* Excellence in comprehension/application of USDA and EU regulatory requirements for production and distribution of regulated biological articles.
* Strong theoretical and practical knowledge of regulated processes and one technical discipline, such as biology to apply knowledge or experience to assigned tasks.
* Ability to make decisions with some supervision regarding the acceptability of product based on documentation provided.
* Excellent attention to detail.