Quality Assurance Specialist - Gmp

100% onsite

Hours: 8am - 5pm

ORACLE Job Title: Change Analyst

Business Function: Document Control

ORACLE Job Title this Position Reports to: Supervisor, Document Control

Job Summary

Client is seeking an experienced Change Analyst, responsible for implementing and maintaining an engineering change order system including product improvements, repairs, and new product releases.

Essential Duties & Responsibilities:

Follows standard practices and procedures when analyzing situations or data. Exercises good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Self-starter to complete tasks with little to no instruction on day-to-day tasks and workload.

Experience leading teams and assuming a leadership role when judgment calls are required in the absence of senior management.

Ability to build strong relationships with employees at all levels of the organization: internal and external

Ability to enforce corporate standards and procedures in accordance with governing guidelines

Perform higher level duties and more complex projects

Coordination with change order Originators to create, revise or obsolete documentation with the appropriate approvals.

Responsible for the Engineering Change Order process to ensure proper approvals and validated changes are released into the system.

Responsible for updating and reproducing Engineering, Manufacturing and Quality documentation for the organization. Ensure that documentation files and history records are accurate and current.

Provide training, work direction and guidance to staff to assure completion of assigned tasks and other duties.

Ensure company staff is adequately trained in the principals, policies surrounding document control and the Agile system.

Track and coordinate change order completion, approval, and implementation.

Generation of Agile training materials

Strong interpersonal skills, time management, and organizational skills

Strong Document Control skills and knowledge

May include other duties as defined by the Document Control department management.

Physical Demands (Please check all applicable boxes)

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Sit; use hands to finger, handle or feel objects, tools, or controls.

Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.

Lifting/moving and carrying products weighing up to 30 pounds.

Qualifications

Education

Bachelors degree, equivalent college courses or equivalent experience

Experience

Years (3+) of related work experience preferred

Skills

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required:

Must be computer literate with strong use of word processing, spreadsheet programs and databases.

Use of some independent judgment and analysis required.

Experience using Oracle Agile PLM software preferred

Experience in a medical device company or biotechnology industry a plus.

Proficient in Oracle Agile ERP and PLM systems

Oracle eBusiness Suite preferred.

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