US_Specialist, QA Release

Boehringer Ingelheim; Athens (GA); On-site; USD 80,000 - 110,000; Full time

Job summary

Boehringer Ingelheim Animal Health USA is seeking an experienced QA Release professional to review and approve batch records, COAs, and production documentation ensuring USDA, FDA and cGMP compliance.

The role covers multiple manufacturing stages, including CMOs, with exposure to change controls, deviations, CAPAs and SAP movements. Strong communication and regulatory knowledge are essential for success.

Qualifications

• BS or MS in a relevant scientific discipline with experience in QA release or documentation review.
• Ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source.
• Excellent written and verbal communication; strong regulatory comprehension (USDA/FDA) and GMP.
• Proficient in quality systems, CAPA/Deviations, change controls and batch release processes.

Responsibilities

• Review and approve batch records and Certificates of Analysis/Conformance for release.
• Perform change control reviews as SME in QA Release.
• Initiate deviations and participate in investigations for root cause analysis.
• Perform SAP transactions for product movements and batch release checks.
• Coordinate and lead project tasks within QA and regulatory compliance scopes.
• Assist with training and ensure timely completion of assigned tasks.

Skills

Documentation Review

SAP

QA Release

Regulatory Knowledge

Attention to Detail

Education

BS degree

MS degree

Tools

MS Office

IDEA for CON

SAP

Learning One Source

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 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, 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 onspecific 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

• BS degree from an accredited institution in a relevant scientific discipline, plus two (2) years of relevant experience required; or MS 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.

Desired Skills, Experience and Abilities

JOB ID

37603

Job function

Manufacturing, operations & production

Career level

Experienced professionals

Organization

Boehringer Ingelheim Animal Health USA

Working time

Full-Time

Job flexibility

On-Site

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. 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