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Boehringer Ingelheim · 1 day ago

US_SR Associate, Quality Control Data

Gainesville, GA

Full-time

Onsite

Entry Level

2+ years exp

Boehringer Ingelheim is a global leader in healthcare, focused on improving lives through innovative products. The SR Associate, Quality Control Data will manage functions in the Quality Control Department, including LIMS and sample life cycle management, ensuring compliance with regulatory requirements and quality assurance support.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Sample Life Cycle Management including responsible for daily sample submission receipt (including the maintenance of the logbook, LIMS, coolers, and freezers), preparation of retention samples and maintenance of retention samples and retention database

Regulatory Compliance including responsible for preparation and shipment of USDA samples using APHIS Form 2020

Documentation Life Cycle Management including responsible for managing Quality Control test documentation of active ingredient and final product (filing and generating associated test reports)

Data Integrity including responsible for Quality Control test record issuance and reconciliation

Information Support including functioning as a Quality Control liaison with Planning, Quality Assurance and Production to provide necessary information regarding samples and test dates to allow proper management of formulation and packaging activities and management of safety stocks and back-order prevention

Product Release including assisting in the preparation of accurate and timely submissions to USDA for product release using the APHIS Form 2008 and international documentation as needed to release product according to applicable procedures

As assigned, assists in Conditional Releases, Early Expiration, Spanish/Brazil/ROW assignments and document creation/revision as needed according to applicable procedures

Accountable to all related USDA, international, and GMP Biologics requirements at the Athens site for maintaining product registrations in >90 countries

Ensures quality samples and data in Quality Control through: Management of samples, Distribution, and reconciliation of test documentation, Filing of test documentation, Generation of test reports as well as Planning and Production support for testing information

Qualification

LIMSQuality AssuranceQuality ControlRegulatory ComplianceRoot Cause AnalysisMicrosoft OfficeDetail OrientedTime ManagementOrganizational SkillsVerbal CommunicationWritten Communication

Required

Associates degree + 2 years of relevant industry experience required

Functional knowledge of computer systems such as laboratory information management systems (LIMS) is required

Solid verbal and written communication skills, including document review and editing skills

Detail oriented

Strong time management skills

Strong organizational skills with ability to multi-task and prioritize

Experience in root cause analysis tools

Ability to understand and comply with Quality Assurance and regulatory requirements (9CFR, Outlines of Production, Change Control, Deviation, CAPA, OOX, etc.)

Computer skills in Microsoft Office applications and the ability to learn new applications quickly and easily

Preferred

Bachelor's degree in a scientific discipline

Functional knowledge of product manufacturing activities is recommended

Previous experience in a Manufacturing environment in Quality Assurance, Quality Control, or Production preferred

Benefits

Competitive compensation and benefit programs

Programs and groups that ensure your health and wellbeing are looked after

Company

Boehringer Ingelheim

Glassdoor4.2

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

https://www.boehringer-ingelheim.com/

H1B Sponsorship

Boehringer Ingelheim has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (13)

2024 (4)

2023 (11)

2022 (7)

2021 (17)

2020 (1)