Temporary Compliance QA Manager - Systems - Alameda, CA

Orbis Clinical is seeking a Temporary Compliance QA Manager - Systems located in Alameda, CA for 12 months.

Job Title: Temporary Compliance QA Manager - Systems

Location: Alameda, CA

Contract: 12 months

Summary/Job Purpose:

QA Manager Systems and Process is responsible for oversight, support, and administration of Computer System Validation (CSV) and Data Integrity, assuring effective and efficient process maintenance to support GxP functions.

Primary role is supporting end users, Business Owners (BOs), Systems Owners (SO and QA, assuring applicable requirements are in place and met, system compliance, managing accounts, evaluating and managing CSV/DI and related changes, deviations and CAPAs, executing on continuous system improvements, and supporting Quality Management Systems (QMS) activities, as applicable.

Essential Duties and Responsibilities:

• As QA Core, support QA Partner:
• Analyze user enhancement requests to deliver solutions that establish and improve business processes, assuring process and system efficiency, elimination of process gaps, enabling automation
• Assemble document user and functional requirements
• Author and execute implementation plans, develop solutions, effectively manage timelines for timely execution
• Perform User Acceptance testing (UAT), Performance Qualification (PQ), Validation testing
• Create and run reports; track follow-up actions to ensure data quality and compliance
• Generate metrics to support business goals, as applicable
• Pro-actively improve monitoring, eliminate user issues, deliver better value to cross-functional teams
• Drive CSV/DI and QMS results, timeliness and compliance in QA, across System and Business Owners, and in cross-functional project forums
• Escalate timely and effectively

Day-to-day business system administration:

• Manage system access and permissions
• Perform QMS activities (changes, deviations, tracking, etc.)
• Design solutions; manage configuration
• Work proactively with users to resolve issues and drive timelines
• Create reports based on defined requirements
• Maintain system documentation and associated records
• Create and run reports; track follow-up actions, ensure data quality and compliance
• Review/approve validation deliverables (URS, FS, IQ/OQ/PQ, etc.)
• Identify, mitigate, escalate and resolve issues and risks
• Author/review CSV, DI records, and QMS records, as applicable (policies, procedures, lifecycle documents)
• Generate metrics to support business goals as requested
• Maintain end-user support information
• Revise business guidance and user reference documentation
• Support internal and external audits/inspections
• Support CSV/DI program

Supervisory Responsibilities:

• None

Education/Experience:

• Bachelor's degree in science or related field and a minimum of 7 years of related experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• At least 5 years of experience with validated applications in a pharmaceutical or regulated environment.
• Experience and knowledge of the quality and regulatory business processes.
• Direct hands-on experience implementing GxP computerized systems and maintaining validated state, and DI.
• Result driven
• Strong process improvement and negotiation skills, driving process excellence.
• Proven business and technology skills, successful in providing customer- oriented technology solutions.
• Proven excellent communication skills, with users, technical communities, cross-functional project groups. Communicates ideas in technical and user-friendly language.
• Collaborative team player, driving for results and timeliness.

Knowledge/Skills:

• Knowledge of System Administration (Veeva Platform (Quality QMS, Quality QDocs)); SaaS systems; Other Regulated Applications (Learning Management Systems, QMS)
• Knowledge of databases and computer networking
• Excellent communication skills (oral, written, presentations)

Working Conditions:

• Environment: Onsite

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $56.12 - $72.41 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.