Description:
Corrective and Preventive Action Specialist
Monday - Friday 8am-5pm (as needed), Hybrid work schedule.
The CAPA (Corrective And Preventive Action) Specialist is the CAPA System Quality Representative and coordinates the inputs and outputs of the System. Leads the development of and implements training for all users of the System, as their functional positions require. Additionally, the individual supports all Quality System/Compliance activities, including but not limited to Quality Systems analyses, development, procedures, training, auditing, and MDR/Vigilance reporting, as assigned. This position drives system improvements to increase product/process quality and organizational efficiency.
Responsibilities
• Coordinates the activities of the CAPA Review Board to ensure the communications of the Board are recorded and the quality
records produced by the Board are maintained per procedure.
• Participates in the review and documentation of issues as they are escalated to the CAPA System.
• Monitors work performed by participants of the CAPA System to ensure that those quality records are generated and maintained according to procedure.
• Gathers and reports measurable data for periodic reviews of the Quality System.
• Collaborates with departmental managers to track data and analyze trends reported at Management Review.
• Provides support for Translational Diagnostics, Manufacturing, R&D, Quality Assurance, and Operations as required to ensure
regulatory compliance, appropriate business planning, and continuously promote Quality First Time.
• Participates in the development and maintenance of processes/procedures for ensuring compliance to internal and external
requirements.
• Provides internal support for review of policies and procedures to ensure compliance with government regulations and
international Quality System Regulations (QSR) including quality system standards such as 21 CFR Parts 803, 806, 820 and
ISO 13485/9000 and ISO 14971, etc.
• Assists in the creation and maintenance of documentation in support of all products through the use of electronic database applications. Archives controlled documents as part of the document control processes. Perform complete and
accurate cataloging/filing of quality records and lab notebooks by executing the issuance and return of materials to their appropriate files and/or locations.
• Leads outreach support of quality system concepts and tools as they are applied throughout.
• Supports communications with scientific and Regulatory bodies as necessary.
• Other duties as assigned by management.
Required:
Bachelor's Degree in business management, biological science, engineering
field or related discipline
Equivalent combination of education and experience will be considered.
Demonstrated proficiency with domestic and international regulations.
Knowledge of process design and implementation, change control, auditing, and document management systems.
Strong interpersonal and organizational skills.
Ability to work in fast-paced setting and cross-functionally with all levels of employees.
Excellent oral and written communication skills. Ability to prepare and present information to groups.
High degree of initiative with the ability to work independently, maintaining accuracy and quality.
Good use of process and business judgment.
Thorough understanding of quality philosophies, principles, systems, methods, tools, standards,
organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics.
Thorough understanding of a quality system and its development, documentation and implementation with respect to domestic and international standards and requirements.
Able to develop and implement quality programs, including tracking, analyzing, reporting and problem solving.
Able to plan, control and assure product and process quality in accordance with quality principles which may include software validation, product and process validation, planning processes, material control, acceptance sampling, and measurement systems.
Thorough understanding of problem solving and quality improvement tools and techniques, including
management and planning tools, corrections, corrective, and preventive actions, and how to overcome barriers to quality improvements.
Knowledge of word processing, spreadsheets, data bases and PowerPoint presentations
Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.
