Administrative Assistant - Short Term

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.

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

18.00 - 22.00

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.