Validation Associate

Lancesoft

Kansas City, MO

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JOB DETAILS

SALARY

$23

SKILLS

Biology, Change Control, Computer Engineering, Computer Science, Continuous Improvement, Data Quality, GMP (Good Manufacturing Practices), Laboratory Equipment, Maintain Compliance, Physical Science, Problem Solving Skills, Process Improvement, Process Validation, Project Planning, Regulatory Compliance, Regulatory Requirements, Sales Qualification, Systems Administration/Management, Technical Leadership, Validation Documentation, Validation Plan

LOCATION

Kansas City, MO

POSTED

1 day ago

Enter Job Description...
This position serves as a validation representative for laboratory validation activities, including Equipment Qualification and system administration. In addition, this position is expected to provide technical guidance as A SME with respect to validation/process deviations and change controls as pertains to validation impact.

II. Essential Functions

Generate, execute and summarize validation documentation for process equipment qualification.
Lead Validation/Qualification/CSV efforts for equipment purchased or modified (FAT, SAT, OQ, PQ).
Coordinate with Quality, technical scientists, and vendors for validation protocols, execution, and final reports
Generate, execute and summarize project plans, conduct and peer review change controls, review validation related exceptions events, as well as provide input to site as a SME.
Contribute to the development and revision of validation concepts, techniques, and standards to ensure compliance with regulatory requirements.
Assist in validation related issue resolutions for all GMP laboratory equipment.
Generate and participate in any change control activities as required.
Participate in any tasks associated with system implementation or upgrades as required.
Lead/support periodic and data integrity reviews.
Participate, support, and drive Continuous Improvement initiatives.

All other duties as assigned

Education and Experience:

Bachelor s Degree in Life Sciences, Physical Science, Computer Science or Engineering field with minimum of 3 years relevant experience, OR
Master s degree in related Life Sciences, Physical Science, Computer Science or Engineering field required with a minimum of 1 years relevant experience, OR
Doctorate degree in related Life Sciences, Physical Science, Computer Science or Engineering field required with a minimum of 1 years relevant experience.

EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.

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/