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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, and may serve as a backup for the QA Release Manager or direct supervisor in the event of their absence.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 several 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.

• Performs documentation review of media fills and media fill protocol approvals as needed.

• Holds quality and reliability as high standards of production and service for own work.

• Follows established quality assurance procedures and understands how factors outside of own work area impact processes and tasks within own work area.

• Change Control:

• Performs review and approvals of change controls as a subject matter expert (SME)in QA Release for routine change controls.

• Performs review and approvals of significant change controls (new facility/new equipment/new product).

• Completes change control action items as assigned.

• Revises existing procedures as changes occur.

• Creates new documents (SOPs/Forms/templates)as needed.

• Deviations/CAPA:

• 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.

• 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.

• Performs assessment and approvals of requests for items that are returned to stock.

• 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. Initiates new specifications with supervisor input as needed for new materials.

• Regulatory:

• Demonstrates understanding of regulations for various countries.

• Routinely reviews regulatory correspondence/audit reports and assures compliance of QA Release procedures.

• Provides input into regulatory filings (OOPs/dossiers).

• Actively participates in external groups (PTEA, AHI)

SR Specialist Requirements

• BS degree in a relevant scientific discipline plus 5 years of relevant experience or MS degree in a relevant scientific discipline + 3 years relevant experience or PhD in a relevant scientific discipline is required for this position.

• Core Competencies:

• Business/Technical Knowledge, Customer Advocacy & Personal Initiative, Communication, Delivering Results, Innovation & Change, Lives Lead and Learn, Teamwork & Collaboration, Quality Orientation/BPE, Problem Solving/Resolution - Developing and Project/Project management - Developing

• Knowledge of Regulatory Requirements & Compliance - Demonstrating

• Quality Competencies:

• Analytical Thinking/Project/Program Management - Developing

• Planning and Organization - Demonstrating

• Skills:

• 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 minimal supervision regarding the acceptability of product based on documentation provided.

• Excellent attention to detail.

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.

All qualified applicants will receive consideration for employment without regard to a person’s 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.