Current Opportunities

Quality Engineer

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Duties and Responsibilities

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• Perform equipment validation activities including author, execute, review, and approve validation and quality documentation for direct / indirect / no-impact systems

• Develop validation project plans, impact assessments, user requirements, commissioning and qualification protocols, summary reports, risk assessments, and traceability matrices; Manage day-to-day validation work with minimal supervision to ensure projects are completed on schedule

• Coordinate for equipment investigations including identify, document, and resolve protocol deviations with cross-functional teams.

• Prepare, review, and approve change controls, CAPAs, and investigation reports that support validation activities.

• Provide technical support for equipment maintenance, repairs, and ongoing system performance.

• Perform validation in alignment with regulatory requirements, industry best practices, and corporate quality objectives.  

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Qualification

• Bachelor’s Degree in engineering, life sciences or technical disciple required or equivalent experience.

• Applicants must be authorized to work in the U.S. without sponsorship

• Must be able to work at client site in North Carolina

 

Experience

• minimum 12 months of relevant  of work experience 

• Experience using Microsoft products (Word, Excel, PowerPoint)

• Knowledgeable of cGMP and 21 CFR Part 11 and Annex 1 regulations

• Frequent travel is required to visit our company's clients.

 

Knowledge, Skills, Abilities

• Outstanding attention to detail and organizational skills.

• Self-starter, independent and dependable.

• Ability to work effectively with minimal supervision.

• Ability to work in a fast-paced environment under pressure, able to multi-task and is results-oriented.

• Effective prioritization skills.

• Requires discretion, great listening skills and independent judgment.

• Highly effective verbal and written communication skills.