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For your reference, we have included the original job posting below.
Quality Assurance Lead - Validated
Job Number:
43879303
Company Name:
Kelly Services
Job Location:
Philadelphia, PA US
Job Category:
Information Technology
Quality Assurance Lead - Validated
Kelly IT Resources has a full time Validation Specialist position with a client of ours in NorthEast Philadelphia. Please review the requirements below and get in touch if you have an interest in learning more...
Summary In this position, the Validation Specialist will be responsible for planning and executing multiple validation projects simultaneously. Heavy interaction with internal customers will be expected, as well as the ability to problem solve and prioritize activities to meet project deadlines. This position requires the ability to drive the computer Validation/Qualification activities including: developing/executing software (Software Development Life Cycle (SDLC)) documents, URS, Functional Requirements, Risk Assessment, Design Specification, IQ, OQ, PQ to completion. Also the ability to provide technical expertise, interpretation and direction to management and user departments to assure compliance with regulatory requirements, company policies and standards. Essential Duties and Responsibilities
Write protocols that challenge the critical parameters related to installation, operation, and performance of regulated systems.
Work within and develop standards and operational procedures for regulated systems.
Monitor regulatory and inspection trends and advise on suitable actions.
Excellent oral and written communication skills in English.
Strong expertise and ability to interview and accurately interpret communication requirements of team members.
Supports change control as validation technical resource and ensures timely completion of required tasks.
Performs all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.
Provide technical expertise, interpretation and direction to management and user in regards to computer Validation, federal regulations and other quality requirements.
Participate in Impact assessment for companywide GxP validated systems to ensure systems remain in a validated state.
Effectively interact with Engineering, QA, IT, and outside vendors.
Conduct Periodic reviews of GxP computerized systems.
Participate in continuous quality systems improvement.
Perform other activities as required.
Education/Experience
Bachelors degree in Computer Science, Chemistry, Life Sciences or Engineering or related field
2 or more years of Project Management experience along with 4 years hands on experience in Computer system validation or equivalent combination of education and experience.
Specific knowledge of computer validation methodologies, software development life cycles, extensive knowledge of cGMPs, 21 CFR Part 11, regulatory requirements and ICH guidelines.
Knowledge of computer network and system security principles.
Working validation knowledge with any of the following system/areas; automated manufacturing systems, lab systems, TrackWise, Empower, EDMS, LIMS, CDAS, IT infrastructure.
Working knowledge of GAMP 5.
Must be proficient in MS-Office.
Ability to work independently and drive projects.
Excellent written and oral communication skill, good decision making skills and time management skills.
About Kelly IT Resources Kelly IT Resources (KITR) is a specialty service of Kelly Services, Inc., a leader in providing workforce solutions. Launched in 1999, KITR provides information technology specialists across all IT disciplines, including operating systems, programming languages, database administration, application development, website design and development, networks, e-commerce, ERP development, software engineering, and project management. Visit .
