Consultant Specialists, Inc. (CSI) · 4 days ago
Quality Assurance Specialist
Philadelphia, PA
Contract
Onsite
Mid Level
$35/hr - $42/hr
3+ years expConsultant Specialists, Inc. (CSI) is seeking a Quality Assurance Operations Specialist to provide quality, technical support and oversight during manufacturing activities. The role involves reviewing batch records, managing deviations, and ensuring compliance with quality documentation and standards.
Staffing & Recruiting
Hiring Manager
Maurice Minnis
Responsibilities
Provide quality, technical support and oversight during manufacturing activities
Review executed batch records and evaluate product and facility deviations; draw conclusions in terms of product disposition at Spark
Open deviations as appropriate based upon Spark 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 prior to 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
Compile and maintain metrics for testing results, quality documentation closure, and disposition and evaluate trending data to identify any irregular trends and notify management as required
Provide administrative project management support for Quality Management System integration and improvement projects
Provide support for Quality Risk Management governance, including maintenance of documentation, risk register, CAPA plans, etc
Support coordination of site Change Control Review Board and change control communications with third party license holder
Prepare certificate of compliance (CoC) and/or certificate of analysis (CoA) for products for clinical and/or commercial materials
Other assigned responsibilities as established by the QA Operations Lead
Qualification
Required
Bachelor's Degree in scientific discipline
Minimum of 3-5 years in a regulated manufacturing environment with exposure to Quality and Manufacturing field
Knowledge of Quality Systems such as Change Control, Investigations and CAPA
Ability to communicate effectively with wide range of personnel
Technical writing skills related to investigation reports
General working knowledge of relevant governmental regulations, cGMP and guidelines
Company
Consultant Specialists, Inc. (CSI)
Consultant Specialists, Inc. is a small, specialized firm, built and operated by staffing industry veterans with many years experience.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase