Quality Systems Specialist

Computer System Validation SpecialistDescriptionGMP/GLP - Change Control / Deviation - Computer System Validation Candidate will be expected to work within the Quality team as the specialist for Computer System Validation. Will be responsible for writing and revising validation documentation focused with the Manufacturing / Laboratory work.This role will be responsible for reviewing and approving validation/qualification protocols/reports, standard operating procedures, investigations, work orders, change documents, reports for projects and maintenance activities. Work in a collaborative team setting with quality counterparts that include Manufacturing Operations and Laboratory Testing. Provide quality and compliance oversight for the qualification, and validation, of manufacturing, laboratory and testing processes. Including, review and approval of qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria. Provide quality and compliance oversight for the commissioning and qualification of site facility spaces and utilities. Including review and approval of Change Controls, Project Validation Master Plans, Commissioning Test Plans, Qualification protocols, SOP's and Summary Reports. Provide quality and compliance oversight for scheduled and periodic maintenance activities within the manufacturing and testing facility. Including, review and approval of documentation supporting Plant and Laboratory Maintenance, whose function is to perform planned (Preventative maintenance) and unplanned (work orders and change controls) maintenance for equipment and instruments. Review and approve Risk Assessments, Change Controls, SOPs, FMEA, Periodic Qualifications, Project Plans, Master Plans. Ability to manage multiple and complex projects, provide status reports and coordinating with other departments and/or outside contractors/vendors to complete validation tasks. Judgment and problem-solving – able to define decision criteria and determine the most appropriate course of action. Planning and organizational skills – able to establish objectives and schedule tasks/resources efficiently. Support technical and quality investigations to resolve issues. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.SkillsValidation, GMP, Change Control, Deviation, LIMS, Electronic Notebook, data integrity, data management, computer system validationTop Skills DetailsValidation, GMP, Change Control, DeviationAdditional Skills & Qualifications•3-5 years of relevant experience or equivalent •Bachelors' degree in a Science related field or equivalent experience •Experience in Writing and Revising •Ability to accomplish the described duties through the use of appropriate computer equipment and software (especially Microsoft Word, Excel, and Outlook) •Must be proficient in Change Control and Deviation •Ability to work effectively as part of a team and to exhibit effective interpersonal skills •Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication •Must have experience working within a GMP or GLP environment •Proficient in Oral & Written communication skillsExperience LevelIntermediate LevelJob Type & LocationThis is a Contract position based out of Philadelphia, PA.Pay and BenefitsThe pay range for this position is $50.00 - $65.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision; Critical Illness, Accident, and Hospital; 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available; Life Insurance (Voluntary Life & AD&D for the employee and dependents); Short and long-term disability; Health Spending Account (HSA); Transportation benefits; Employee Assistance Program; Time Off/Leave (PTO, Vacation or Sick Leave)Workplace TypeThis is a hybrid position in Philadelphia, PA.Application DeadlineThis position is anticipated to close on Sep 11, 2026.