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Quality Assurance Specialist ROCGJP00039210 * Hourly pay: $35-$40/hr * Worksite: Leading biotechnology company (Philadelphia, PA 19104 - Onsite) * W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL * 40 hours/week, 10 Month Assignment A leading biotechnology company is seeking a Quality Assurance Specialist. The successful candidate will provide quality, technical support, and oversight during manufacturing activities. Quality Assurance Specialist Responsibilities: * Review executed batch records and evaluate product and facility deviations; draw conclusions in terms of product disposition. * Open deviations as appropriate based upon Manufacturing Team and/or CMO notification; provide evidence of document closing at time of product disposition. * Assure all deviation/investigations, change controls, CAPAs, and/or other required documentation are completed and closed before material/lot release. * Review and evaluate QC testing records and any associated OOS investigations. * Review, write, revise, and approve SOP's, technical documents, and reports. * Perform inspection and release of materials used for production, and review vendor certificates for completeness/compliance against approved specifications, and collaborate with Material Management to release incoming materials for production. Quality Assurance Specialist Qualifications: * 3-5 years in a regulated manufacturing environment with exposure to the Quality and Manufacturing field. * Bachelor's Degree in a scientific discipline. * Pharma background preferred. * Knowledge of Quality Systems such as Change Control, Investigations, and CAPA. * Ability to communicate effectively witha wide range of personnel; * Technical writing skills related to investigation reports. * General working knowledge of relevant governmental regulations, cGMP, and guidelines. * Ability to participate in cross-functional teams in root cause analysis and solution identification. * Ability to work collaboratively in the process of conflict resolution to resolve deviations, effectively CAPAs, and identify requirements to implement changes in a controlled GMP environment. (H)