Quality Assurance Specialist

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: 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 Amgen requirements relating to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Safety, and Controls. 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 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. #J-18808-Ljbffr