Position: Quality Engineer II, Req ID: ROCGJP00025099
Location: Hillsboro, OR (100% onsite)
Duration: 12 months contract

Job Description: 

Education and Experience: 

• Software that will be used in the role: eValRoche, VeevaVault and one QMS
• B.A. or B.S. degree (preferably in Engineering or Life Science) and at least two years of experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.
• Basic knowledge of engineering principles and concepts applicable to Process as they relate to system performance and regulatory agency.
• Some Knowledge of Risk Assessment Methodology (PHA, FMEA, FTA), is preferred.
• Ability to work collaboratively in cross-functional teams to achieve milestones and goals.
• Basic knowledge of EU and US CGMPs and applicable validation guidance.
• Ability to make sound decisions about quality and technical subjects.
• Ability to communicate clearly and professionally both in writing and verbally.

Main Purpose of the Position: 

• Provide technical review and approve validation deliverables ensuring proper study design and execution.
• Maintain the compliance status of the assigned validation areas at a state of inspection readiness.
• Working with multiple functions, leading solutions to validation issues following cGMP regulations and the client’s standards.
• Site Quality technical and regulatory subject matter expert and technical leader for validation study methods, design, and regulatory requirements.
• Provide Quality Assurance oversight to Validation, Revalidation, and Quality Risk Management projects to meet good business practices and the requirements of applicable Health Authorities.
• Assist in the integration of the risk management program with quality systems including, but not limited to, Validation, CAPA, Change Control, APQR, Complaints, and Inspection Readiness.
• Provide technical review and approve validation deliverables ensuring proper study design and execution.
• Maintain the compliance status of the assigned validation areas at a state of inspection readiness.

Roles and Responsibilities: 

• Working with site and corporate level functions, serve as the Quality representative in the design and implementation of area and cross-functional projects and initiatives.
• Support the validation program during regulatory agency inspections.
• Troubleshoot and support the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Be accountable for behaviors as described in the client’s Competencies.
• Provide input into the design and presentation of validation performance metrics.
• Must be able to work independently and organize and manage projects by demonstrating progress against defined milestones and schedules.

Technical Duties/Responsibilities

• Provide Quality oversight (including technical requirements and regulatory expectations) of site validation efforts.
• Review and approve validation documents (e.g., Project Plans, User Requirements, Protocols, Validation Deviations, Summary Reports, etc) for CGMP and technical content.
• Provide technical guidance for study design including sampling plans, acceptance criteria, and rationale.
• Provide technical and quality validation assessment and approval for engineering and process changes.
• Collaborate with departments to ensure validation activities are executed compliantly, with efficiency and effectiveness.
• Review, assess, and approve Quality Risk management documents.
• Participate in the risk stages of procuring new equipment.
• Collaborate with departments to ensure risk management and validation activities are executed efficiently and effectively.
• Review and approve Alarm Review documentation.
• Provide input into investigations with potential validation impact.
• Provide input and collaborate with other site/functional units and Corporate on validation standards and procedures.

About the Company:
TalentBurst, Inc.

TalentBurst is an award winning IT and Accounting & Finance staffing firm headquartered in Boston with branch offices in San Francisco, Miami, Milwaukee, Toronto, Bangalore, and Gurgaon. Our clients include the leading social media, technology, banks, utilities, pharmaceutical, and biotech companies.
We work with 75 of the Fortune 500 companies and work on 2,000 new job requisitions per month. Our recruiting team is one of the most successful in the industry. We have a strong reputation for treating our employees well and helping you find your next dream employer. BenefitsAt TalentBurst, one of our founding principles has been to provide our employees with the best benefits available. To adhere to this principle, we have a broad benefits offering. Our recruiters are dedicated to connecting you with awesome career growth opportunities with leading companies.

Company Size:
5,000 to 9,999 employees

Industry:
Staffing/Employment Agencies

Founded:
2002

Website:
http://www.talentburst.com/