PLANT CAPA INVESTIGATION LEADER

PLANT CAPA INVESTIGATION LEADER 

Fairfield, CA

EXP 2-5 yrs

DEG Bach

RELO

BONUS

Job Description.

The primary responsibilities of the CAPA Coordinator are multifunctional and include management of the plant Exception Report and Corrective action/Preventative Action (CAPA) program, Customer Complaints and NPI.  

Primary responsibilities include implementation and maintenance in the following areas:

Initiating Exception Report, assessed impact and writing investigations and/or reviewing investigations.

Investigating complaints and summarizing reports, trending complaints, establishing corrective actions and provide weekly and monthly update to Site Management team.

Coordinate and oversee all new products, and other new projects that involved Quality Systems

Facilitate Planned Deviation meeting/schedule coordination and plant planned deviation implementation.

Problem analysis and corrective action (CAPA).

Technical resource within plant when it comes to problem solving

Training on the ER/CAPA system (as needed)

Major Responsibilities:

Assemble CAPA information for quarterly management review presentations to the plant staff. Reports metrics to all levels of the organization

Monitor and analyze plant CAPA metrics and information. Ensure all deadlines are met for action items

Coordinate and oversee all new products, and other new projects that involve Quality Systems.

Ensure that ER/CAPA documentation is compliant with Division and Corporate policy/procedure requirements. Ensure investigations are approved by correct areas.

Train new personnel on the CAPA system.

Assist manufacturing and other departments in identifying root cause and implementing effective corrective actions for those circumstances where quality standards are not met.  

Investigate and complete complaint investigations as requested and per timelines provided from Division. Review batch records for critical data and post summary to the complaint database.

Facilitate Planned Deviation meeting/schedule coordination, plant Planned Deviation implementation, Electronic Planned Deviation coordination, Planned Deviation follow up and close out. Create and maintain supplemental forms and DOPs within the QDMS system.

Facilitate communications and coordinate activities to support NPI initiatives to assure successful launches of new products.

Arbitrate and resolve differences among various departments to assure that proposed changes follow the Plant, Division, and Corporate guidelines.

Coordinate document changes with Plant and Division representatives

Ensure Customer Complaint responses are being addressed in timely manner and coordinate to ensure all follow up pertaining to Customer Complaint activities are follow through, this include obtaining/requesting samples for analysis.

Weekly/Monthly/Quarterly/Annual Metric Reporting (CAPA, work order discrepancies, ER’s, SQE’s, Alert Levels/Trends, released on time and in full (MPS))

Can send out samples as needed.

Can document and lead a CAPA meeting as needed.

Responsible for implementing and maintaining the effectiveness of the quality system.

The CAPA Coordinator is responsible for initiating, assessing impact, writing the investigation, Corrective Action plan (if needed), implementing and maintaining the effectiveness of the CAPA Quality System.

Assembles CAPA information for weekly, monthly and quarterly management review presentations to the plant staff. Reports required metrics to all levels of the organization.

Monitors and analyzes plant CAPA metrics and information. Ensure all deadlines are met for action items.

Investigating complaints and summarizing reports, trending complaints, establishing corrective actions and provide weekly and monthly update to Site Management team.

Reviews non-conformances that impact plant operations and products and provides recommendations and corrective actions and effectiveness plans. Ensures that ER/CAPA documentation is compliant with Division and Corporate policy/procedure requirements. Ensure investigations are approved by correct areas.

Responsible for New Product Introduction, Customer Complaints, and Batch disposition (if needed).

Assists manufacturing and other departments in identifying root cause and implementing effective corrective actions for those circumstances where quality standards are not met.  

Training of new personnel and refresher training on the CAPA system.

Other responsibilities assigned by Plant Quality System Manager.  

Accountability / Scope/Budget:

The CAPA Coordinator reports to the Manager, Plant Quality Systems. The CAPA Coordinator’s responsibility impacts all nutritional products produced in the plant and the preservation of the company’s continued well-being through compliance to regulations and avoidance of major business interruptions from regulatory agencies such as the FDA. This position is responsible for all exception reports and ensures they are in compliance to company policies, procedures, and established regulatory standards. They are also responsible for all Customer Complaints and NPI launches at the site. This position requires a high degree of independence and must perform all tasks with minimum supervision.

Education:

Bachelor’s Degree required in Science or Technical Field.

Background:

Knowledge of applicable regulatory standards and Good Manufacturing Practices. 

Four years quality assurance experience preferred.  

Must have strong written and verbal communication skills.  

Must be organized and able to prioritize duties and responsibilities.  

Must demonstrate initiative, innovation and sound analytical problem solving skills.  

Must be able to interact with all levels and disciplines of employees.  

Must be able to manage multiple, high priority projects.

Must be attention to detail, multi-tasking and flexible in work hours

IDEAL CANDIDATE

CAPA experience

FDA interaction