Quality Control Engineer III/IV

Job Req code: 928

Category: Quality Systems

Organogenesis corporate headquarters is located in Canton, Massachusetts, including manufacturing, R&D, customer service, reimbursement and other corporate teams supporting our full range of products. We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing.

Author, execute, and summarize validation protocols. Coordinate and manage validation project execution for equipment, process, cleaning, and computer related systems. Ensure protocols, records, and procedures are in compliance with 21 CFR 11and current Good Manufacturing Practices (CGMP). This position utilizes strong facilitation, problem solving, and customer service mind-set to help improve performance through process improvement/maturation.

Key Responsibilities

• The QC Engineer prepares, executes and summarizes validation protocols and other related documents to support various projects related to equipment qualification, instrument qualification, test method validation and process validation related to QC.
• Plans and conducts the analysis, inspection, design, test, and/or integration to assure the quality of assigned product or component.
• Coordinate validation activities with plant support groups (Operations, Maintenance, Technical Services, Quality, etc.) for timely protocol executions
• Perform visual inspection of finished product.
• Coordinate or participate in development projects including laboratory, pilot plant or plant scale investigations to provide improved procedures, equipment or processes for existing products.

REQUIREMENTS

Preferred Education and Experience

• B.S. in Chemical Engineering, Biomedical Engineering, or Chemistry is required.
• 3-5 years of industry experience with functional analysis QC or method development of biology-based assays preferred. Other QC, process engineering, manufacturing experience will be considered.
• GMP and FDA experience preferred.
• Understands and operates basic equipment and technologies, as applicable to job function.
• Basic knowledge of descriptive statistics and acceptance sampling.
• Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Comply with all company and site policies and procedures.
• Knowledge of Quality System and SOP procedures as well as industry regulations and standards such as CGMP, GLP, FDA, USP, and/or ISO.
• Understands job-specific transaction processes, including Documentum and Access data entry and maintenance.
• Knowledge of appropriate risk management tools such as FMEA.
• Basic problem solving skills.
• Understands and execute cost reduction and productivity improvement tasks using Process or Design Excellence techniques.
• Understands Document Control Policies and Procedures