Nonconformance CAPA Specialist
The Nonconformance CAPA Specialist 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.
Job Description (including but not limited to the following):
- 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.
- Collaborate with Deviation, CAPA, and SCAR owners.
- Helps drive a culture of continuous improvement.
- Assist with regulatory and 3rd party inspections.
- 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
- Owns projects as assigned. Performs other tasks as assigned.
Skills and Responsibilities:
- Minimum 2-3 years in pharmaceutical operations required. High School Diploma or equivalent required. Bachelor’s degree in health sciences preferred. Internal auditing experience is a plus.
- 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 take 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.
- Required working knowledge of basic Microsoft Office applications. Some knowledge of data analysis software and reporting (e.g., Excel, etc.).
Temp to hire position located in the Conejo Valley area. Pay is $26-28 hourly. Candidate will be required to pass drug screening and background check.
Royal Staffing Services will consider for employment qualified Applicants with Criminal Histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring.