Quality Assurance Systems Specialist (cur_1_132372@curatelyai.net)

Job Description

Job Description

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".

Job Title: Quality Assurance Systems Specialist

Location: Bend, Oregon 97703

Duration: 12 Months

Pay: $49 hr. on W2

Job Description:

• Minimum five years' experience in pharmaceutical / biotechnology or related industry, including two years in quality unit.
• Experience with equipment & analytical instrument qualification and computerized systems validation.
• Working knowledge of GxPs, Regulations (such as 21 CFR Part 11 & Annex 11), and related industry standards (e.g. USP).

Job Tasks

• Support commissioning and qualification and computer system validation projects.
• Write, Execute, Review and Approve validation protocols, reports, and system lifecycle documents, as required.
• Collaborate across functions, including IT, QC, Automation, QA, and Vendors, as required, to review and approve qualifications and validations.
• Perform assessments as part of change and risk management.
• Act as subject matter expert and ensure consistency in validation strategy/approach for equipment, systems, computers, and methods.
• Support trouble shooting of systems and staff training, as required.
• Participate in client and regulatory inspections.
• Assist with investigations, root cause analysis, and corrective and preventative action, as needed.
• Enhance the promotion of Data Integrity (DI) culture and raise DI awareness across the site.
• Improve site DI maturity as defined.

Education :

• Bachelor’s Degree in science (minimum)

Establish and facilitate site DI forum including a consistent and structured agenda but not limited to:
Ongoing DI activities (remediation CAPAs, trainings)

• Sharing from Global (best practice, case study, any other DI updates/requirements)
• Sharing from Site (best practice, case study, deviations with potential DI impact, etc.)
• Ad hoc topics (e.g. Inspection preparation)
• Establish regular DI GEMBA walkthrough.

Level of Authority

• Controlled documents and records generation, review, and approval.
• Supervise conduct of validation activities and advise on course of action for problem resolution.
• Make decisions related to system commissioning, qualification, and validation activities.
• Work with stakeholders to resolve and reduce potential DI risk from findings, and gap assessments.

Environmental/Physical Demands

• Personal Protection Equipment.
• Occasional light lifting, less than 25 lbs.
• Travel as needed.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.