Method Validation Quality Engineer

Lancesoft

St. Paul, MN

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JOB DETAILS

SALARY

$40

SKILLS

Communication Skills, Consulting, Data Analysis, Document Change Management, Establish Priorities, External Audit, Government Regulations, Internal Audit, Manufacturing, Mentoring, People Management, Procedure Development, Product Development, Production Systems, Progress Reports, Project Tracking, Quality Assurance Methodology, Quality Engineering, Receiving Inspection, Regulations, Resource Management, Schedule Development, Team Lead/Manager, Test Plan/Schedule, Time Management, User Groups, Validation Documentation, Validation Plan, Validation Testing

LOCATION

St. Paul, MN

POSTED

26 days ago

Title: Method Validation Quality Engineer
Location: St. Paul, MN 55117
Duration: 5 Months, till year end

Main Purpose Of Role
Summarize the main purpose of the role.

Responsible for creating and implementing the Client Division test method validations. Will document existing test methods, write test method validation protocols and executes test method validation. Ensures that validation activities are implemented for systems and processes used in receiving inspection, manufacturing, according to requirements and standards as listed in the current Quality Systems.

Main Responsibilities

Represent Client Division during internal and external audits of validation projects and documentation.
Write test method validation documentation against production processes and systems in compliance to internal and external requirements utilizing well developed technical and regulatory skills.
Manage the execution of validation protocols, as protocol directors, in assurance of timely and cost efficient completion through specialized experience and training.
Evaluate validation results of validation protocol executions employing specialized experience and training.
Consult with owner/user groups to summarize validation results in final reports incorporating strong communication skills and experience.
Manage Validation Master Plans (VMPs) and associated reports related to new product development and existing production processes, systems, and controls.
Perform validation assessment on Change Management documentation including, but not limited to document changes, system changes, and process changes.
Track and report validation progress of corporate validation projects through departmental project tracking tools.
Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks.
May lead a project team of moderate scope.
Provides guidance to less experienced staff.
Acts as a mentor to lower level individual contributors.
Influence exerted at peer level and occasionally at first levels of management.
Plans, organizes, and prioritizes own daily work routine to meet established schedule.
Exercises authority and judgment within defined limits to determine appropriate action.
Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.

Experience/Background
Experience Details

5 + years of related work experience with a good understanding of specified functional area.
Working technical knowledge and application of concepts, practices and procedures.
General understanding of business unit/group function.
Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
Exercises judgment within defined procedures and practices to determine appropriate action.
Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

About the Company

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

Method Validation Quality Engineer

Lancesoft

St. Paul, MN

About the Company

Lancesoft

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