Quality Assurance Engineering Manager jobs in Hickory, NC

The QA Specialist II – Engineering/Validation is responsible for cGMP compliance ensuring all FDA regulations, internal procedures/specifications, and other regulatory requirements are adhered to as it relates to review and approval of engineering/validation specific documentation. He/she must ensure all equipment installed, qualified or validated at the site meet cGMP requirements. This position requires the ability to prioritize workload in alignment with defined timelines. The individual should be proactive in identifying potential issues and communicating with the Engineering and Validation departments.  

Job Responsibilities 

• Perform Quality review/approval of URS, FAT, SAT, IQ,OQ,PQ protocols and summary reports. 
• Perform Quality review/approval of P&IDs, electrical schematics and engineering drawings.
• Perform Quality review/approval of CMMS asset records.
• Perform Quality review/approval of equipment/instrumentation/process validation protocols and summary reports.

• Perform Quality review/approval of maintenance validation protocols and summary reports.
• Perform Quality review/approval of cleaning validation protocols and summary reports.

• Perform Quality review/approval of Engineering/Validation change controls.
• Identify and assess potential risk by analysis of data, observation of processes and execution of root cause analysis through SWOT, FMEA, etc.
• Serve as Quality subject matter expert concerning Engineering/Validation activities.
• Represent the company during contact with the FDA and other regulatory agency audits 
• Consult with subject matter experts and/or functional area managers for technical supervision and complex issue resolution. 

Experience Requirements  

• Must possess strong knowledge of sterile drug product manufacturing.
• Must be detail-oriented with exceptional planning and organizational skills.

• Must be an effective communicator both up and down the organizational structure.

• Must be able to negotiate effectively in order to ensure commitment and alignment across functional leaders
• Must have experience managing the resolution of roadblocks impacting release timelines
• Minimum 5 years’ experience working in FDA regulated organization or similar regulated industry.
• Must have engineering experience.

Education Requirements  

• Bachelor's degree required in a scientific discipline or related field.  In some instances, a combination of education and relevant work experience may be acceptable in lieu of a Batchelor’s degree.

EOE, including disability/vets.