SR Associate, Quality Control Data

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SR Associate, Quality Control Data

Description

The SR Associate, Quality Control Data will manage the following functions in the Quality Control Department. This includes LIMS, Sample Life Cycle Management and Quality Control test documentation life cycle management in compliance with procedures and regulatory requirements. The incumbent will be responsible as an approved USDA sampler and providing Quality Assurance and Production support as needed. 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 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.

Duties & 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.

Requirements

• Associates degree + 2 years of relevant industry experience required; Bachelor's degree in a scientific discipline, preferred.
• Functional knowledge of computer systems such as laboratory information management systems (LIMS) is required.
• Functional knowledge of product manufacturing activities is recommended.
• Previous experience in a Manufacturing environment in Quality Assurance, Quality Control, or Production preferred.
• 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.

Desired Skills, Experience and Abilities

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