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Quality Systems Specialist II

Oceanside, CA 92058

Posted: 10/26/2023 Job Number: 20751538

Job Description

  • Bachelor's degree in science or equivalent work experience
  • Experience (3-4 years) working in a GXP or ISO regulated environment
  • Ability to interpret regulatory standards and implement sound risk-based decision making that ensures compliance with applicable governance
  • Experience (1-2 years) in a Quality related role in a controlled work environment
  • Experience in executing internal or supplier audits and hosting external audits nice to have
  • Must have excellent skills in organization, negotiation, problem solving, and time-management
  • Able to attend to detail and act decisively
  • Ability to work under pressure, manage several tasks at once and meet tight deadlines
  • Must have excellent interpersonal, written, oral presentation and verbal communication skills
  • Proficient in Microsoft Word, PowerPoint, Access and Excel
  • Lifting up to 50 pounds may be required
  • While performing the duties of this job, the employee is regularly required to use their hands and fingers to operate a computer keyboard, mouse, and telephone keypad or to write, as well as speak and hear
  • Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus

  • The Quality Systems Specialist II is a crucial role in conducting all aspects of Quality within our assigned business project portfolio
  • He/she is responsible for managing, coordinating, facilitating, and implementing quality standards based on cGMP, ICH, and ISO requirements and guidance across all our products
  • The incumbent in this position adheres to our quality governing methods, develops and controls quality procedures, and participates in developing programs for improving product quality
  • The role will focus on implementation of the Quality Management System and ensuring compliance with our policies and procedures and conformance with customer requirements
  • Participate in the development, implementation, management, and integration of a Quality Management System (QMS) for all our production activities and products
  • Execute routine Document Control activities per our SOPs, QMS, and applicable regulatory requirements
  • Write and revise Quality SOPs, and other related procedures
  • Provide user assistance and conduct employee training on document control and record management systems and procedures
  • Maintain the Training program and deliver employee training on applicable quality SOPs, regulatory requirements, or standards under the guidance of Quality Management
  • Manage and update our training matrix to ensure employees are appropriately trained on all applicable documents in a timely manner
  • Follow up on outstanding/overdue training
  • Participate in and support the implementation of the EQMS system
  • Support the company audit program conducting internal audits and/or hosting client or 3rd party audits
  • Participate in the initiation, documentation, and management of quality events (e.G.: deviations, CAPA, change control, complaints)
  • Assist in root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements
  • Collect and analyze Quality performance data, statistically analyze, and report to management on quality issues, trends, and losses
  • Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented
  • Serve as a trainer for other Quality personnel as needed
  • Provide general support for the overall Quality Management System and perform other related quality duties as assigned or identified
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