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Compliance QA Manager - Systems

Alameda, CA 94502

Posted: 10/04/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 614950 Is job remote?: No Country: United States

Job Description


Target PR Range: 57-67/hr
*Depending on experience

SUMMARY/JOB PURPOSE:

The Compliance QA Manager - Systems is responsible for the oversight, support, and administration of Quality Management Systems (QMS) to ensure these are effective and efficient, and maintained to support GxP functions. Supports end users and QA requirements, account management, and evaluates changes for implementation and continuous improvement initiatives.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
As QA Core, supports QA Partner:
·       Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and growth of the organization.
·       Gather and document user and functional requirements
·       Participate in the authoring and execution of implementation plans, development of solutions and manage project/change timelines
·       Perform User Acceptance testing (UAT), Performance Qualification (PQ) and Validation testing, if applicable
·       Day to day business system administration:
o   manage system access and permissions
o   perform change management activities
o   design solutions and manage configuration
o   liaise with users to resolve issues
o   create reports based on defined requirements
o   maintain system documentation
·       Create and run reports; track follow-up actions to ensure data quality and compliance
·       Help generate metrics to support business goals
·       Maintain end-user support information
·       Manage updates to business guidance and user reference documentation
·       Continuously look for ways to improve monitoring, user issues and deliver better value to the customer
·       Support activities related to internal and external audits/inspections
·       Support activities related to Computer System Validation and Data Integrity program.
·       Oversee and maintain the Integration tool with the Leaning Management System, ComplianceWire, if applicable

SUPERVISORY RESPONSIBILITIES:
·       None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

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 working on 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.
·       Strong process improvement skills and orientation.
·       Must have proven business and technology skills with success providing customer- oriented technology solutions environment.
·       Proven strong communication skills interacting with user and technical communities.
·       Ability to communicate ideas in both technical and user-friendly language.
·       Collaborative working approach.

Knowledge/Skills:
·       General knowledge of System Administration with the Veeva Platform (Quality QMS, Quality QDocs)
·       Working knowledge/experience with Other Regulated Applications, such as Learning Management Systems and Quality Management Systems.
·       General knowledge of database and computer networking
·       Working knowledge/experience with SaaS systems

 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Alameda, CA

Ready to kickstart your career in the vibrant and thriving area around Alameda, California? This picturesque region, nestled in the San Francisco Bay Area, offers an abundance of job opportunities with a backdrop of stunning views and a rich cultural scene. Discover the charm of Alameda with its historic landmarks like the USS Hornet Museum, unique cuisine at Alameda's vibrant restaurants, and diverse entertainment options at venues like the Alameda Theatre & Cineplex. With easy access to outdoor activities at Crown Memorial State Beach and the Alameda Marina, this area provides the perfect blend of work and play. Explore our job listings today and make your mark in this enchanting location!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.