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Boehringer Ingelheim · 1 day ago

SR Specialist, Commercial Quality

Duluth, GA

Full-time

Onsite

Mid, Senior Level

4+ years exp

Boehringer Ingelheim is a global leader in the pharmaceutical industry, committed to improving the lives of patients and customers. The SR Specialist, Commercial Quality is responsible for overseeing compliance of local quality systems and acting as the local Management System Owner, ensuring that local procedures support these systems.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Perform responsibilities of local Management System Owner (MSO) for assigned quality system(s), including writing and maintaining local procedures, training local personnel, actively participating in Global MSO Network

Perform timely investigations for logistic incidents and deviations

Work closely with third parties on resolution of open events and deviations

Identify and monitor US trends through system queries and ensure communication, escalation, and resolution. Perform review of trends with Senior Management (Commercial Quality and Commercial Operations) at least annually

Track relevant KPI and implement continuous process improvement initiatives

Perform duties of Key User for Quality Systems (i.e. LOS, GOTrack), including writing/maintaining local procedures, training local personnel on system use, requesting roles for end users, and being local expert and first line of help for all local end users

Ensure US Marketing Site Quality unit and related areas follow BI regulations and all local regulatory requirements (i.e. 21CFR 211.198 and 514.80) for assigned management systems

Assist in Batch Acceptance activities and release of finished goods to the US market

Qualification

Quality Systems ManagementGMP ExperienceRoot Cause AnalysisAnimal Health Industry ExperienceTechnical WritingPlanningOrganizationCommunication SkillsAttention to DetailTeamwork

Required

B.S. degree from an accredited institution in life sciences, engineering, or computer science

At least four (4) years of experience working in the animal health industry or related field

Demonstrates and maintains excellent oral and written communication skills

Attention to detail in a fast-paced, high volume environment imperative

Ability to work in a team environment and independently

Demonstrated interpersonal and communication skills, planning and organization skills, attention to detail, initiative and independent judgment are required

Possess the scientific expertise and product knowledge to identify and monitor technical product complaint trends across all BIAH product types and species

In depth understanding of regulatory and corporate requirements, cGMPs, technical writing, and root cause analysis

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

Preferred

Quality or GMP experience preferred

Benefits

Competitive compensation and benefit programs

Health and wellbeing programs

Company

Boehringer Ingelheim

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Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.

Founded in 1885

Ingelheim Am Rhein, Rheinland-Pfalz, DEU

10001+ employees