SR Specialist, QA Release

Boehringer Ingelheim•Gainesville, GA

About The Position

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 an opportunity for all employees to collaborate internationally, offering visibility and the opportunity to directly contribute to the company's 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, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The basic purpose of this position is to review and approvals of batch records, government release documentation and release of starting materials in process and finished biological product. This position ensures 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 products received from third 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. This position is a deputy to the Qualified Person (QP)/Person Responsible for Release (RfR).

Requirements

BS degree in a relevant scientific discipline plus five (5) years of relevant experience OR MS degree in a relevant scientific discipline plus three (3) years relevant experience OR PhD in a relevant scientific discipline is required for this position
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
Knowledge of Regulatory Requirements & Compliance
Analytical Thinking/Project/Program Management
Planning and Organization
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.
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.

Nice To Haves

Desired Skills, Experience and Abilities

Responsibilities

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.
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.
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.
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.
Actively participates in project teams as assigned by supervisor.
Coordinates and leads projects within group without supervision.
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.
Develops training plans and trains others, including training outside of area of responsibility.
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.
Participates in internal audits as assigned by management.
Participates in 3rd party 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.