Administrative Assistant

Administrative Assistant - Short Term

We are searching for an experienced Administrative Assistant - Short Term at our Feasterville facility.

Primary Duties and Responsibilities:

Position Summary

Responsible for 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 supporting 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.
• Lead problem-solving activities, root cause analysis, and/or documentation of these activities using industry standard root cause investigation tools.
• Support activities to resolve quality issues, such as revising SOPs, implementing process improvements or sharing findings with the teams involved.
• Perform effectiveness verification after CAPA closure.
• Trend complaint data using Quality System Reports, charts, and other quality tools as needed.
• Lead proactive projects to improve internal processes.
• Independently interface with the customer regarding critical complaints, through written or verbal communication including emails, conference calls or investigation letters.
• 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.

Required Qualifications:

Education

• Bachelor's Degree, certification or equivalent in the Medical Packaging Industry or Quality Assurance field.
• Experience in a regulated industry such as food, medical device or pharmaceuticals.

Experience

• Strong Knowledge of GMP and ISO requirements.
• 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.

Hourly

Hourly

Our company provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.