Quality Engineer OTCAct Consulting • Lewisville, TX
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Quality Engineer OTC
Act Consulting • Lewisville, TX
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.permanent]
- [job_card.temporary]
[job_card.job_description]Quality Management System (QMS) – responsible for duties relating to Quality Systems including but not limited to batch record review, document control, change control, annual OTC product review, validation support, stability support, review of quality events, and investigation of market quality events. Assist with approaches to continually improve and streamline processes to meet business and compliance requirements including development and incorporation of best practices. Supports additional special projects related to these objectives as required. Inspection Readiness - Must remain knowledgeable about significant global regulatory changes that could impact client's products. Assists with the implementation and monitoring of related systems, policies, and procedures. Supports efforts to ensure proper compliance quality management systems are maintained and that the global Quality standards are met and consistently followed. This support includes conducting internal system audits of client. manufacturing centers as well as client's International Subsidiaries. Provides support for audits of client. by external agencies (FDA, TDH, Health Canada, etc.). Root Cause Analysis – Performs and advises on root cause analysis for product quality issues and works issue through containment phase of corrective action process. Supports investigation of internal and external failures to determine cause. Partners with various departments (including Quality, R&D, Manufacturing Operations, Purchasing, Package Engineering, and Legal) to request input to aid in feedback investigation, root cause identification, and implementation of actions to respond to both immediate issue resolution and long-term systemic resolution and prevention of recurrence. Follows up to verify that changes in the systems are implemented and monitors the systems over time to verify effectiveness.
ACT Consulting has an immediate need for a Product / Quality Engineer with our direct client.
Please take a moment to review the job description. If this is something you are interested in, please send a copy of your resume to or contact us at for additional details.
ACT Consulting is a owned and operated staffing company providing our clients with candidates on a national basis for contract, contract to hire, and direct hire engagements. Our clients are comprised mostly of Fortune companies, primarily in the areas of Information Technology, Engineering, Professional, Accounting and Finance. Location : Lewisville,TX (zip code-) Duration : Long term contract Title : Product / Quality Engineer Rate - $ / hr on W. Summary
Top qualification
- investigations root cause analysis or corrective actions - Critical
- Experience computer system validation - Critical
- Annual product review - Would be nice
- Experience with validation, process, cleaning or equipment validation - Would be nice
- Any experience around any type of stability program - Would be Nice
Certified Quality Auditor Preferred
Certified Quality Engineer
Certified Quality Manager Job Summary
Serves as technical / subject matter expert for compliance quality related issues and works to resolve these issues and improve quality globally. Serves as internal auditor and member of Quality Systems team. Assists in the day-to-day operations of Quality Systems processes including but not limited to Batch Record Review, Over the Counter (OTC) Drug and Nutritional Product Release, Annual Product Review (APR), Validation Support, Change Control, Training, Document Control, Document Distribution, Investigation and Root Cause Analysis, and Inspection Readiness. Responsibilities
Education : Bachelor / University Degree
Education Focus : Chemistry, Microbiologoy Thanks & Regards Paul Joseph ACT Consulting Talent Acquisition Lead Phone : Fax :
Visit ACT Consulting at to view our open positions.
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Quality Engineer • Lewisville, TX
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