Quality System Associate

Summary

The Quality System Associate will lead the development, administration and execution of the GMP CAPA Program, which includes the Deviation, Corrective Action and Preventive Action (CAPA), and Supplier Corrective Action Request (SCAR) processes. This role is responsible for improving the CAPA Program, providing oversight for the processes, training impacted staff, executing investigation, action implementation, and effectiveness verification activities as assigned, and reporting progress to Operations management.

General Duties and Responsibilities:

• Responsible for the development and execution of the GMP CAPA program and processes for packaging, equipment, facility and procedural changes.
• Provides oversight for all GMP CAPA Program records.
• Supports change owners in the writing, executing and administration of Deviation, CAPA, and SCAR records.
• Collaborate with change owners as necessary to facilitate completion of CAPA program activities.
• Ensures activities are executed per Standard Operating Procedure.
• Tracks timeliness of Deviations, CAPAs, and SCARs against pre-defined milestones.
• Determines key quality indicators for the GMP CAPA program and process.
• Reports Deviation, CAPA, and SCAR status and progress to Operations management.
• Owns projects as assigned.
• Collaborate with Deviation, CAPA, and SCAR owners.
• Helps drive a culture of continuous improvement.
• Assist with regulatory and 3rd party inspections.
• Establishes a good quality of work
• Participates in team meetings and strategizing sessions
• Participates in continuous improvement initiatives
• Behaves ethical in all situations and reports or challenges unethical behavior of others
• Performs other tasks as assigned.
  
  
  

Supervision:

Received: Quality System Manager

Given: N/A

Equipment:

Standard office equipment, computers, full-body suit, goggles, cap, booties, gloves, and respirator.

Physical/Cognitive Requirements:

• Working knowledge of FDA GMP regulations and quality system regulations/requirements
• Knowledge of manufacturing processes.
• Good communication skills at all levels, both written and verbal; both individually and in a group setting.
• Strong skills in analytical thinking and problem solving.
• Ability to perform multiple tasks and ability to effectively manage conflict.
• Ability to work in teams to obtain results.
• Proactively identify issues and taking action.
• Good decision-making skills. Ability to make decisions with limited information.
• Effectively manage change and comfortable changing direction and acting without complete information.
• Good organizational and prioritization skills.
• May be required to work longer than the typical 8-hour workday.
• Sedentary position that may requires pro-longed long periods of desk work.
• Requires light physical duties in keeping work areas clean and organized. Regularly required to walk the production and warehouse areas.
  
  
  

Computer Skills:

• Required working knowledge of basic Microsoft Office applications. Some knowledge of data analysis software and reporting (e.g., Excel, etc.).
  
  
  

Miscellaneous Requirements:

• Maintain a strong attendance record.
• Must be able to pass screening, drug test and background check. Adhere to company’s drug-free workplace policies.
  
  
  

Attitude:

• Must be enthusiastic, concerned with job, and the company as a whole, openness with management, and punctual.
• Self-discipline and a desire to achieve results.
• Must be flexible and willing to change.
• Must be detail oriented.
• Team player, professional, and achieve high quality results.
  
  
  

The hiring range for this position in Camarillo, CA (Remote) is $24.25 per hour. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills and experience among other factors. A bonus may be provided as part of the compensation package, in addition to a full range of other health and welfare benefits.