Gerresheimer · 1 month ago
Capa Specialist- Internal Investigations (Process Quality Associate)
650 Highway 74 S, Peachtree City, Georgia, United States
Full-time
Onsite
Mid Level
4+ years expGerresheimer is a global partner in the medical device industry, specializing in pharmaceutical and cosmetic packaging solutions. The Capa Specialist will be responsible for coordinating internal deviations, monitoring corrective actions, and supporting quality assurance tasks to ensure compliance and continuous improvement in production processes.
Health CareManufacturing
Responsibilities
Independent coordination and processing of internal deviations in collaboration with relevant departments and other interfaces
Independent monitoring of on-time processing of internal deviations and defined corrective actions (including long-term CAPAs)
Independent review of 8D reports for consistency, plausibility, adequacy, and clarity, particularly with respect to:
Definition of affected products or materials
Root cause analysis
Corrective and preventive actions
Effectiveness verification
Advising production regarding required rework or implementation of changes
Independent evaluation of blocked stock to determine disposition (e.g., release, rework, scrapping)
Participation in processing customer complaints
Support continuous improvement initiatives (e.g., 5S)
Perform additional quality assurance tasks in production as assigned (e.g., process monitoring, hygiene checks, sterilization activities, etc.)
Processing time of internal deviations (critical deviations)
CAPA (Corrective and Preventive Actions) overdue rate
Frequency of recurring errors
Qualification
Required
Very good knowledge of relevant quality management (QM) guidelines
Good knowledge of quality management systems
Good understanding of production processes and manufacturing methods
Strong technical comprehension
Good command of English, spoken and written
Good IT user skills (e.g., MES/SAP, MS Office)
Knowledge acquired through at least a 3-year technical education program, supplemented by a minimum of 4 years of experience in operational quality assurance
Motivation for achievement and innovation
Action orientation, conscientiousness, and flexibility
Sensitivity and strong interpersonal skills
Sociability and team orientation
Emotional stability, resilience, and self-confidence
Company
Gerresheimer
About Gerresheimer Gerresheimer is an innovative system and solution provider and global partner for the pharma, biotech and cosmetics industries.
10001+ employees
H1B Sponsorship
Gerresheimer has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$298.08M2023-04-18Post Ipo Equity· $298.08M
2017-02-17IPO
2004-11-11Acquired
Leadership Team
Fred Howery
Senior Plant Director, President/CEO
Recent News
2025-12-24
2025-12-24
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