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Quality Assurance Specialist

Quality Assurance

Ashtabula, OH, US

+ Added - 08/09/2025

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The Quality Assurance Specialist is responsible for supporting and maintaining quality system processes in compliance with regulatory standards, including cGMP, ISO 9001, and FDA requirements. This role plays a critical part in ensuring that all quality assurance standards, processes, and controls are consistently upheld throughout manufacturing and operational activities.

Pay: 65,000 - 70,000 Annually

Direct Hire

Key Responsibilities:

+ Review, generate, correct, and archive GMP documentation related to the manufacture of final product

+ Conduct and support internal and external audits as assigned

+ Perform review and release of raw materials, intermediate products, and finished goods

+ Support incoming material and tote inspections

+ Review and approve deviations, out-of-specifications (OOS), nonconformance reports, and investigations

+ Coordinate CAPA activities and ensure proper documentation of all quality incidents

+ Maintain compliance with SOPs and quality systems

+ Assist in the resolution of product quality issues and nonconformities

+ Write, revise, and approve standard operating procedures (SOPs) and work instructions

+ Review and approve protocols, reports, and other controlled documents

+ Facilitate and deliver GMP and SOP training

+ Generate and manage quality metrics and reports to support continuous improvement

+ Support QMS-related functions including calibration tracking and product release

+ Scan and archive GMP documentation in compliance with company retention policies

+ Provide assistance to Environmental and Safety programs as needed

General Requirements:

+ Bachelor’s degree in a scientific discipline or equivalent experience

+ Minimum 2 years of experience in a cGMP/FDA-regulated environment (preferred)

+ Familiarity with ISO 9001 and Quality Assurance/Compliance functions

+ Strong knowledge of regulatory guidelines including ISO 9001:2015, cGMP, CFR 210/211, FDA, HACCP, Food Safety Management, and ICH Q7

+ Experience in manufacturing, preferably chemical processing

+ Proficient in Microsoft Office (especially Excel); experience with QT9 is a plus

+ Knowledge of Statistical Process Control (SPC) is preferred

+ Strong time management, organizational, and conflict resolution skills

+ Excellent verbal and written communication skills with the ability to professionally address quality-related issues

+ Training experience is a plus

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

INDBH

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.