Immediate need for a talented Quality Risk Management Specialist. This is a 04+ Months Contract opportunity with long-term potential and is located in Bothell, WA(Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID:24-35362
Pay Range: $75 - $80/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- Contribute to the writing, coordination, review, and maintenance of the Bothell Risk Management Standard Operating Procedures (SOPs) and associated documents.
- Ensure product risk management documentation/files are maintained, with good documentation practices and in compliances with Client Quality System
- Facilitate planning, execution and completion of risk assessments by providing guidance to cross-functional team members
- Conduct risk reviews and escalate findings, as appropriate, to QRM team
- Track the status of risk mitigation actions through to completion
- Track the implementation of corrective actions associated with risk assessments and verify the actions are align with source event
- Responsible for maintaining the Bothell Quality Risk Catalog/Registry
- Support the creation, revision and approval of Quality Risk Management Reports
- Proactively deploy methods and techniques (e.g. Six Sigma/Lean, FMEA, Root Cause Analysis, etc.) to improve effectiveness of the Risk Management program.
- Collaborate to improve Quality Risk Methodologies and practices
- Generate data for Quality Risk Management Performance Metrics
Key Requirements and Technology Experience:
- Key Skills-(("QUALITY RISK MANAGEMENT" OR "RISK MANAGEMENT") AND (FDA OR GMP OR CGMP OR PHARMA OR PHARMACEUTICAL OR "PHARMACEUTICAL COMPANY" OR "PHARMACEUTICAL COMPANIES" OR "PHARMACEUTICAL INDUSTRY" OR "MEDICAL DEVICES" OR "MEDICAL DEVICE") AND (QUALITY).
- A minimum of 5 years of relevant Quality experience in a GMP/FDA regulated environment.
- Understanding of Quality Risk Management principles and application within the quality systems
- Strong technical writing skill set and ability to critically review reports while effectively expressing Quality principles.
- Quality and continuous improvement
- Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
- Strong project planning skills.
- Strong knowledge of cGMPs and Health Authority requirements
- Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems)
- Strong experience and thorough understanding of risk management tools with in-depth knowledge of cGMPs and applicable FDA regulations guidelines and industry best practices
- Proven experience working as a detailed oriented team player with effective planning, organization and execution skills
- Experience with performing risk assessments using a variety of tools (e.g. FMEA, FTA, HACCP, etc).
- Strong computer skills with MS Office (e.g. Word, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System).
- Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
Our client is a leading Pharmaceutical Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.