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Battelle · 1 day ago

Quality Control Specialist

Columbus, OH

Full-time

Hybrid

Entry Level

2+ years exp

Battelle is a leading organization in research and development, managing national laboratories, and delivering critical services. The Project Quality Specialist role focuses on supporting medical device product development teams by managing documentation, ensuring compliance with Good Documentation Practices, and collaborating with cross-functional teams to maintain quality standards.

Biotechnology

Responsibilities

Manages project file documents through the site document control system

Prepares documents for data collection; ensures correct versioning and aligns formats and templates to internal standards and quality system requirements before distribution

Enforces Good Documentation Practices (GDP) in records; escalates issues, if identified

Completes document review and reconciliation: performs completeness checks, traces data to source, and resolves discrepancies with authors/testers

Collects, reconciles, and processes executed records; routes for review/approval via DocuSign or eQMS workflows

Serves as secondary witness for testing when required; confirms forms are prepared, entries made contemporaneously, and witnessing meets procedural requirements

Provides administrative project support

Monitors training compliance and project conformance to the Quality Management System requirements, customer requirements, and regulations

Collaborates with cross-functional teams to support quality objectives

Interfaces with internal stakeholders and contributes to customer quality support, as needed

Identifies recurring issues and escalates opportunity improvements to Project Manager, Quality Engineer, and/or Quality System Manager to drive continuous improvement, efficiency, and compliance

Qualification

ISO 13485Document control systemsDocumentation PracticesMicrosoft OfficeFDA 21 CFR 820E-signature routingAttention to detailOrganizational skillsCommunication skills

Required

Associates Degree in a related field and/or 2 years of applicable technical experience in document control, quality assurance or regulated operations in a medical device or closely related field

Experience working under an ISO registered Quality Management System or related regulated environment in document control systems and processes

Excellent proof-reading skills with attention to detail

Strong organizational and communication skills

Strong computer skills, particularly proficient with Microsoft Office (e.g., Word, Excel)

Preferred

Exposure to customer quality interactions

Working knowledge of FDA 21 CFR 820, ISO 13485, GLP/GMP principles and Good Documentation Practice(s) (GDP), with emphasis on data integrity in test execution and recordkeeping

Experience in electronic system process flows and e-signature routing (e.g. DocuSign)

Benefits

Balance life through a compressed work schedule: Most of our team follows a flexible, compressed work schedule that allows for every other Friday off—giving you a dedicated day to accomplish things in your personal life without using vacation time.

Enjoy enhanced work flexibility, including a hybrid arrangement: You have options for where and when you work. Our Together with Flexibility model allows you to work 60% in-office and 40% remote, with Monday and Tuesday as common in-office days, dependent on team and position needs.

Take time to recharge: You get paid time off to support work-life balance and keep motivated.

Prioritize wellness: Stay healthy with medical, dental, and vision coverage with wellness incentives and benefits plus a variety of optional supplemental benefits.

Better together: Coverage for partners, gender-affirming care and health support, and family formation support.

Build your financial future: Build financial stability with an industry-leading 401(k) retirement savings plan. For most employees, we put in 5 percent whether you contribute or not, and match your contributions on top of that.

Advance your education: Tuition assistance is available to pursue higher education.