Post Market Quality Specialist

Oliver Healthcare Packaging; Pennsylvania; On-site; USD 70,000 - 100,000; Full time

Job summary

Oliver Healthcare Packaging is seeking a Quality CAPA Specialist to manage Internal CAPA and customer complaint processes in line with procedures and regulatory requirements. The role leads or supports investigations and process improvements while coordinating with cross-functional teams.

The position requires strong analytical and communication skills, proficiency with MS Office and SAP, and the ability to write reports and procedures. Occasional evening/weekend work may be needed.

Qualifications

• Two years’ experience in a quality-related position, preferably in a regulated industry such as food, medical device or pharmaceuticals.
• Strong analytical skills, including ability to apply concepts such as fractions, percentages and proportions to practical situations.
• Solid verbal and written communication skills.
• Strong organizational skills and the ability to effectively manage time and multitask.
• Ability to write reports, business correspondence, and procedures.
• Software skills including MS Office and SAP.
• Read, analyze, and interpret SOPs and Regulatory Standards.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Responsibilities

• Manage Internal CAPA and customer complaint processes to standards.
• Obtain background information, data, samples and trace IDs for investigations.
• Confirm material disposition using specs and procedures.
• Communicate quality issues to the team and assign follow-up activities.
• Evaluate investigations and approve closure.
• Trend CAPA data using quality reports and tools.
• Interface with customers via written or verbal communication.
• Participate in internal audits and ISO registrar audits.
• Provide backup support for the Post Market Quality Supervisor.

Skills

Analytical skills

Verbal & written communication

Organizational skills

SAP

MS Office

Tools

SAP

MS Office

Job description

Position Summary

Responsible for managing the Internal CAPA process and administering the customer complaint process in compliance with written procedures and Regulatory requirements, as well as leading or supporting investigation and process improvement activities.

Primary Responsibilities / Essential Functions

• Responsible for managing the Internal CAPA process and administering the customer complaint process in a timely and organized manner:
• Obtain background information on the quality issue.
• Obtain production data information and/or corresponding samples for investigative purposes.
• Obtain trace identification information.
• Confirm material disposition using specifications and procedures.
• Communicate details of the quality issue to a team to determine required follow up activities.
• Distribute assigned activities to investigators.
• Evaluate and approve completed investigations.
• Evaluate evidence of actions and documentation before closing record.
• Manage quality records from initiation through closure.
• Communicate and collaborate with supporting team members to complete activities in a timely manner.
• Support problem solving activities, root cause analysis,and/or documentation of these activities.
• Support activities to resolve quality issues, such as revising SOPs, implementing process improvements or sharing findings with the team’s involved.
• Perform effectiveness verification after CAPA closure.
• Trend CAPA data using Quality System Reports, charts, and other quality tools as needed.
• Interface with the customer through written or verbal communication, including emails, conference calls or investigation letters, as needed.
• Participate in Customer and ISO registrar quality system audits. Provide support for resolving resulting action items.
• Participate on an Internal Audit Team performing multiple audits each year.
• Provide back up support for the Post Market Quality Supervisor.
• Perform additional tasks as needed by the Post Market Quality Supervisor.

Basic Qualifications

Education

• Two years’ experience in a quality-related position, preferably in a regulated industry such as food, medical device or pharmaceuticals.

Experience

• Strong analytical skills, including ability to apply concepts such as fractions, percentages and proportions to practical situations.
• Solid verbal and written communication skills.
• Strong organizational skills and the ability to effectively manage time and multitask.
• Ability to write reports, business correspondence, and procedures.
• Software skills including MS Office and SAP.
• Read, analyze, and interpret SOPs and Regulatory Standards.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Preferred Qualifications

• Strong knowledge of ISO 13485:2003.

Special Requirements

• Ability to work evenings and/or weekends as needed.