Cole-Parmer Engineer, Quality in Franklin, Massachusetts
Job Title: Engineer, Quality
Reports To: Director, Quality and Regulatory Assurance
Position Location: Franklin, MA
FLSA Status (Exempt/Non-Exempt): Exempt
The Quality Engineer is an intermediate position within the QC Testing Department of Antylia Scientific. This role ensures the QC Testing Laboratory is operational on a daily basis to meet company objectives as well as ensure cGMP and ISO 13485 compliance. Reviews all QC testing data packets and product specifications to ensure product quality and compliance. Acts as subject matter expert for QC molecular testing and conducts training of employees as needed.
• Supervise the QC Testing laboratory personnel, set testing schedules to meet in process, product release, validation and stability requirements, maintain adequate inventory levels, and ensure Standard Operating Procedures (SOP) for the testing laboratory are implemented for compliance.
• Perform reviews of all In-process and Final Product testing for accuracy and completeness in a timely manner to meet company objectives.
• Maintain data bases for trending quality data, analyze and report out of trend results.
• Coordinates with QA/QC Manager and/or QA/RA Director on validation and stability projects for ZeptoMetrix products including: writing necessary validation and stability protocols, scheduling, setting up testing packets, reviewing data, writing validation and stability reports, and ensuring all studies are completed according to written protocols.
• Write and implement required SOPs for QC testing for new/transferred products and equipment.
• Act as a subject matter expert for QC testing assays and assist with troubleshooting issues, assay verification, and perform training and testing assays if needed.
• Initiate, review, and revise company SOPs, QC records, cleaning records, and other compliance documentation as needed.
• Participate in design control and risk management activities as needed.
• Perform equipment validation as needed.
• Compose audit responses to Internal Quality Audits with corrective actions and perform actions necessary for compliance and audit closure.
• Contribute to the maintenance of the company's process deviation, NCR, CAPA and Complaint systems, and verify implementation of corrective actions to ensure continuous improvement.
• Maintain the quality system in a state of inspection readiness by ensuring ongoing compliance with FDA and current ISO 13485 regulations.
• Review and approve quality control assay data and file as necessary, report non-conformances, forward completed quality records to QA, and maintain data trending databases and records.
• Maintain and systematically review relevant department SOPs and coordinate with QA/QC Department on revisions when required.
• Performs other duties as assigned.
• Bachelor’s Degree in life sciences related field required
• 3-5 years’ experience in Quality in GMP environment
• Working knowledge of current ISO 13485 and FDA 21 CFR 820. Ability to respond to internal and external quality audits and perform root cause analysis and risk assessment activities.
• Knowledge of QC testing procedures, current ISO 13485, and 21 CFR Part 820 regulations.
• Proficient with Microsoft Office software; experience building and using databases (e.g. Microsoft Access, Excel) preferred.
• Excellent technical writing, communication, and organizational skills.
• Attention to detail.
• Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints
• Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization
• Strong work ethic and an ability to excel within a rapidly changing and growing organizationThis position has not been approved for Relocation Assistance.
The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.