Senior Quality Assurance Engineer-TPI

Job Description

Position Title: Senior Quality Assurance Engineer - TPI

Position Description: Protingent Staffing has an exciting FTE Senior Quality Assurance Engineer - TPI opportunity.

Job Responsibilities:

• Contribute to development and implementation of the Quality Program for TPI. Author, revise, and manage the approval of site procedures and policies related to Quality.
• Provide Quality-related training to colleagues involved in the TPI enterprise.
• Initiate risk-management activities and involvement in risk-based decision making. Balance the requirements for safety, such as radiation safety, in all quality initiatives.
• Support the Quality Assurance CAPA system; assist in developing corrective actions; monitor implementation.
• Develop and implement a supplier qualification program. Monitor supplier performance.
• Participate in Quality system audits (supplier, customer, and internal audits) as required. Contribute to resolution of audit findings and follow up.
• Key contributor to Change Control involving product or process changes.
• Develop processes for validation/qualification of equipment, cleaning, and/or manufacturing processes. Review and approve results.
• Assemble, analyze, and report QA data metrics to detect trends and identify areas for improvement.
• Perform other general duties associated with the position as required by supervision.
  
  
  

Job Qualifications:

• Bachelor’s level degree in Science or Engineering
• 6 years’ industry experience in a regulated production environment (e.g., ISO 9001, cGMP pharmaceutical or radiopharmaceutical industries), including 3 years of prior experience in a Quality Assurance role.
• Experience working within a quality program compliant to FDA/cGMP requirements Title 21 CFR 210/211 and ICH Guidance; preferably, experience in an operational/production radiopharmaceutical facility.
• Must have keen attention to detail with the ability to read and understand requirements such as federal regulations, national codes and standards. Interpret these standards into TPI documents and provide guidance to personnel regarding these requirements.
• Strong organizational and communication skills, including technical writing, teamwork and interpersonal skill.
• Certification in a pharmaceutical Quality-related discipline a plus.
• Familiarity with ISO 9001 Quality Assurance standards, 21 CFR 210/211 regulations and ICH Guides.
• Must demonstrate flexibility in adjusting to changing priorities and schedules in a dynamic environment. Occasional evening or weekend work might be required to support production operations.
• Actual position starting level and title will be determined based on assessment of qualifications.
• Military experience is a plus
• The successful candidate will possess a high degree of trust and integrity, communicate openly and display respect and a desire to foster teamwork.
  
  
  

Job Details:

• Job Type: Direct Hire
• Location: Everett, WA.
• Salary Range Level 12: $169,922 - $235,464.
• Export control regulations require candidates to be a U.S. Citizen, U.S. Legal Permanent Resident, or of a protected person status
  
  
  

About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.