Compliance QA Manager – BB255

Compliance QA Manager – BB255

BB255

Alameda, CA

4 Months

The Compliance QA Manager - Systems is responsible for the oversight, support, and administration of Client’ 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:

· manage system access and permissions

· perform change management activities

· design solutions and manage configuration

· liaise with users to resolve issues

· create reports based on defined requirements

· maintain system documentation

· Create and run reports; track follow-up actions to ensure data quality and compliance

· Reviews and approves validation deliverables (URS, FS, IQ/OQ/PQ, etc.)

· Identifies, mitigates, escalates and resolves issues and risks

· Authors and review CSV, DI policies, procedures, lifecycle documents

· 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 (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

WORKING CONDITIONS:

Environment: primarily working indoors, performing office work.

TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Job Types: Full-time, Contract, Temporary

Pay: $50.00 - $75.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off

Application Question(s):

• What hourly rate are you seeking on a W2?

Education:

• Bachelor's (Preferred)

Experience:

• implementing GxP computerized systems: 1 year (Required)
• Regulatory Industry: 1 year (Required)
• Pharmaceutical Industry: 1 year (Required)
• Compliance: 5 years (Required)
• QA: 5 years (Required)
• UAT: 1 year (Required)
• Validation Testing: 1 year (Required)
• System Administration with the Veeva Platform: 1 year (Required)
• SaaS Systems: 1 year (Required)

Work Location: In person

Salary : $50 - $75