CAPA Manager

Gerresheimer; Peachtree City (GA); On-site; USD 80,000 - 100,000; Full time

Job summary

A manufacturing company is seeking a CAPA Manager to coordinate corrective and preventive actions. This role involves managing quality issues, engaging in customer complaints, and ensuring compliance with quality standards. Candidates should have a technical degree and at least 5 years of experience in a manufacturing environment.

Qualifications

• Minimum 3 years of technical university degree in related field.
• 5+ years of experience in industrial/pharmaceutical sector.

Responsibilities

• Manage CAPA processes and documentation.
• Lead investigations and present results.
• Support audits and customer visits.

Skills

Production and manufacturing technologies

Quality management systems

Statistical and problem-solving methods

Project management

Handling customer complaints

Education

Technical university degree in relevant field

Tools

Quality-related software

Data analysis tools

Job description

Job Description

Job Purpose:

The CAPA Manager is responsible for independently managing and coordinating the corrective and preventive action (CAPA) processes within the organization. This role is pivotal in handling quality issues, customer complaints, and production deviations, with the goal of maintaining and improving the quality management system through effective problem-solving and cross-functional collaboration.

Key Responsibilities:

• Independently coordinate CAPA processes including investigations, root cause analysis, and implementation of corrective and preventive measures.

• Lead and present results to internal and external stakeholders, including customers.

• Prepare comprehensive documentation such as 8D reports and technical analyses.

• Participate in and support audits and customer visits.

• Propose and implement optimization measures and assess their effectiveness.

• Manage projects related to quality improvements and process enhancements.

• Utilize statistical and analytical methods to drive decisions and improvements.

• Represent the quality department in cross-functional problem-solving scenarios.

• Ensure adherence to regulatory and company-specific quality standards.

Qualifications:
Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Qualifications:

• A technical university degree (minimum 3 years) in a field such as plastics technology, glass technology, mechanical engineering, mechatronics, or electrical engineering.

• A minimum of 5 years of professional experience in a comparable role within an industrial or pharmaceutical manufacturing environment.

Required Skills and Competencies:

Professional Skills:

• Strong knowledge of production and manufacturing technologies.

• Deep understanding of quality management systems and methodologies.

• Experience with statistical and problem-solving methods (e.g., root cause analysis, 8D).

• Advanced project management capabilities.

• Proficiency in handling critical customer complaints and production problems.

Methodological Skills:

• CAPA process expertise.

• Change control management

• Quality management manual (QMM).

• Document control and data integrity

• Hygiene and safety regulations.

Digital Competence:

• Advanced user-level IT proficiency.

• Familiarity with data analysis tools and quality-related software.

Additional Information

• Monday-Friday (8am-5pm)