Post Market Quality Specialist

Oliver Healthcare Packaging; New Britain Township (Bucks County); On-site; USD 70,000 - 90,000; Full time

Job summary

Oliver Healthcare Packaging is seeking a CAPA/Quality Specialist to lead the Internal CAPA process and administer the customer complaint program in accordance with written procedures and regulatory requirements. You will gather background information, obtain production data, coordinate investigations, and support root cause analysis, process improvements, and verification after CAPA closure.

Strong analytical, writing, and communication skills are essential.

Qualifications

• Strong analytical skills and the ability to apply concepts to practical situations.
• Solid verbal and written communication skills.
• Strong organizational skills and time management.
• Ability to write reports, business correspondence, and procedures.
• MS Office and SAP software proficiency.
• Ability to read, analyze, and interpret SOPs and regulatory standards.
• Ability to present information effectively to managers, clients, and the public.

Responsibilities

• Manage the Internal CAPA process and administer the customer complaint process in a timely and organized manner.
• Obtain background information on the quality issue.
• Obtain production data and samples for investigations.
• Obtain trace identification information and confirm material disposition per procedures.
• Communicate quality issue details to the team to determine follow-up activities.

Skills

Analytical skills

Verbal & written communication

Org skills

Report writing

MS Office

SAP

SOPs & regulatory standards

Presentation skills

Tools

MS Office

SAP

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 l eading 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 i nvestigators .
• 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 Q uality 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

• T wo years’ experience in a quality -related position , preferable 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 procedure s .
• S oftware 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.