Document Control Analyst

Description

100% onsite

Hours: 8am - 5pm

Possibility of extension

***experience with equipment (IQ/OQ/PQ, maintenance, etc) is a plus

***We are looking for candidates with strong experience document control someone that has a foundation on how to route documents in the workflow, review documents, know what to review and understand drafts, redlines and templates.

***We would like for them to help us in projects and it would be a plus if they can handle projects, meaning they know how to build a plan, a self starter, they can communicate and represent information well, and if they are able to analyze reports and see trends

Skillset Matrix Manager Notes:

• Technology Requirements (I.E Programs, systems, etc:): We prefer someone that knows MediaLab, proficient in Microsoft Office Suite with Technical Writing skills as highly desirable

What does a typical day look like? (daily tasks) Typical daily routing revolves around processing change orders, reading emails, communicating to internal customers, scanning documents., uploading documents to MediaLab, writing quality inspection documents

Preferred background/prior work experience? Strong background in Document Control & Quality Systems

Priority soft skills: Has good communication skills, innovative, has initiative, has passion, and engaged

Job Summary

• Biotheranostics is seeking an experienced Change Analyst, responsible for implementing and maintaining the document control and change order system.

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 Change Order process to ensure proper approvals are implemented into the system.
• 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 change order system.
• Track and coordinate change order completion, approval, and implementation.
• Generation of MediaLab training materials
• Strong interpersonal skills, time management, and organizational skills
• Strong Document Control skills and knowledge
• May include other duties as defined by Quality 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

• Bachelor’s 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.
• Experience in a medical device company or biotechnology industry is required.
• Experience using MediaLab is highly desirable.
• Technical Writing skill is preferred.
• MS Office