Associate Auditor, GI Quality Assurance

Company: Boehringer Ingelheim
Location: Athens
Posted on: June 13, 2021

Job Description:

Description:

Description\:

Provides RDQA support to new product development and registrations for Biological R&D. Implements procedures to ensure the integrity of all research outputs intended for regulatory submissions.

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\:

• Manages and executes the audits of studies in support of vaccine licensure.

• This includes but is not limited to\:

• Audit of protocols, data and reports for method validation, bioanalytical and clinical studies for accuracy, completeness and compliance to regulatory requirements applicable guidelines and procedures

• Issuance of timely and accurate audit reports

• Interact with study personnel to resolve audit observations efficiently

• Identifies opportunities for quality improvements, gains approval from RDQA Management or site management and assists in developing plans or systems for implementing the quality improvements

• Assists in RDQA support of Master Seed/Cell Laboratories, including review of protocols, data, reports, and dossiers to support EU GMP compliance and USDA approval

• Assists in conducting audits of R&D departments for compliance with regulatory directives and corporate, divisional and departmental policies and procedures and communicates observations to management.

• Reviews both site and RDQA SOPs for compliance with regulatory directives and BIAH quality standards

• Provides support for regulatory inspections (USDA, ANSES) on and off-site

• Maintains an awareness of USDA and international requirements, guidelines and relevant statutory requirements to verify that submittable studies meet the requirements.

Requirements\:

• Education (minimum)\: BS/BA degree from an accredited institution in the life sciences.

• Zero to one (0-1) years’ experience in quality assurance or quality control (Associate Auditor)

• One to two (1-2) years’ experience in quality assurance or quality control (Auditor)

• Knowledge of USDA regulations and guidelines

• Ability to work autonomously or in a team environment is required.

• Excellent communication skills are required.

• Fluent in MS Word, Excel, PowerPoint, and good presentation skills are needed.

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

Who We Are\:

At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more?  Visit boehringer-ingelheim.com and join us in our effort to make more health.

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.

Keywords: Boehringer Ingelheim, Athens , Associate Auditor, GI Quality Assurance, Other , Athens, Georgia