Specialist Quality Assurance

Job Title: Quality Assurance Specialist
Location: Onsite,27540, Holly Springs, NC
Work Schedule: 8:00 AM – 5:00 PM (Local Hours)
Duration: 2+ Years, Possibility of Extension
 
 
Top 3 Must-Have Skill Sets

• 5–10 years of experience.
• Biotech/Pharma industry experience is required.
• Experience/knowledge in commissioning, qualification, and validation, including utility systems validation for:
  • Water for Injection (WFI)
  • USP Water Systems
  • Clean Steam
  • Clean Air
  • Compressed Gases
• Strong understanding of regulatory requirements, industry standards, and regulatory trends.
• Demonstrated ability to provide sound quality guidance and make data-driven, risk-based decisions with great attention to detail and a high degree of accuracy in GMP documentation.
• Ability to provide updates to senior management, identify potential issues, and follow assignments through to completion.

 
Description

• Provide QA oversight and release of facility and utility including approval of procedures, protocols, change control oversight and reports.
• Partner to troubleshoot problems as they occur on ANC utility systems (i.e. Water for Injection, Compressed Air, Clean Steam, Heating Hot Water Skids, Water/Steam Sampling, Process Gas Equipment, and other equipment in the CUB).
• Provide quality guidance and support during execution of commissioning and qualification testing, reviewing, and approving changes and discrepancies, as required.
• Author, own, review and approve controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports, Work Instructions, Forms, etc.
• Provide quality oversight for quality records including deviations/CAPAs, change controls and work orders ensuring adherence to procedural requirements and confirming assessments and evaluations of different stakeholders are complete and accurate.
• Ensure that all activities and related documentation for facilities, equipment, materials, and processes comply with applicable regulations and our requirements relating to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Safety, and Controls.
• Support continuous improvement initiatives.
• In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.

 
Basic Qualifications

• Doctorate degree OR
• Master's degree and 3 years of experience OR
• Bachelor's degree and 5 years of experience OR
• Associate degree and 10 years of experience OR
• High school diploma/GED and 12 years of experience

 
Possible Extension
Yes.
 
Red Flags

• Lack of demonstrated GMP experience in an operational setting.
• Weak written or verbal communication skills.
• Inability to work effectively in a cross-functional matrix environment and build relationships with stakeholders.
• Poor attention to detail or lack of accuracy in task execution and GMP documentation.

 

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $30.00/hr – $40.00/hr.