Quality Assurance Associate

Company Overview

We are passionate about our employees. We strive to create an environment that is stimulating and motivating and a culture that fosters mutual respect, teamwork, and career development. Come join the Keystone team so we can build your career together!

In addition to competitive starting salaries, we offer a wide variety of competitive benefits, perks and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Please visit our website at  to learn more about Keystone Industries and career opportunities.

• Title:
  
  Quality Assurance Associate
• Schedule:
  
  8:00 am - 4:30 pm, M-F, with some flexibility.
• Location:
  
  Gibbstown, NJ (08027) with requirements to work at another office in Cherry Hill, NJ weekly.
• Salary Range: $55,000 - $80,000 annually, based on experience and qualifications.

• Define/clarify cGMP and Quality Management requirements across all divisions and help coordinate Keystone's efforts for meeting them. Coordinate/revise/assist with the GMP/GDP training program and ISO Awareness program as needed.
• Oversee and coordinate quality system elements as assigned, including but not limited to the Internal Audit system, Customer Complaint Handling, Deviations, Non-Conformances and CAPA systems.
• Perform batch record reviews. Ensure proper follow-up and close-out of any issues and that appropriate documentation is completed and maintained.
• Perform Internal and support External (supplier) audits, when qualified.
• Assist the Quality Assurance Specialist and/or Manager in managing the Supplier Quality Management System.
• Assist with quality system documentation including but not limited to writing, revising and proof-reading Quality System Procedures, Keystone's Quality Manual, department or task instructions, SOP's, checklists, forms, etc.
• Prepare and maintain product technical documents, validation documents, change managements and other technical and quality system documents and records as necessary. Provide guidance to other personnel to ensure record requirements for project planning, design control, purchasing activities, customer complaints and other feedback, etc. are met.
• Assist with Management Reviews of the Quality System. Review and summarize trend analysis data as requested such as customer complaints, product, and system non-conformances, returns and credit data, CAR/PARs, etc. Help prepare Management Review Reports, assist with data presentation and ensure appropriate meeting minutes are recorded, and follow-up activities are performed and documented.
• Assist with project planning, design control and risk assessment responsibilities as necessary.
• Inform the Senior Quality, Regulatory and/or Executive Management team members of problems found within the quality system and updates on improvements or necessary corrective actions.
• Assist with external regulatory, customer and ISO Notified Body audits. Help coordinate/document resulting corrective action closeout activities.
• Handle customer communication as necessary.
• Perform additional duties/tasks as needed or requested by management.

• 0-3 years of Quality Assurance and ISO Quality System experience.
• General knowledge of Quality System Elements (FDA CFRs, ISO standards, Complaint Handling, CAPA, Deviation, Change Management, Document Control, etc.).
• Exceptional computer skills (Microsoft Office).
• Exceptional interpersonal skills—ability to interface and communicate/collaborate at all levels internally and externally.
• Strong writing skills.
• Ability to successfully work on multiple job tasks/projects simultaneously.
• Project management and organizational skills.
• Time management skills and deadline driven.
• High attention to detail.

• Knowledge of FDA cGMP for medical devices and Pharmaceutical.
• Understanding of current ISO 13485 and supporting ISO standard requirements.
• Knowledge of system auditing techniques and requirements.
• ISO Quality System Training.
• Internal Auditor Training.

• Bachelor’s degree in a technical field (chemistry, biology, biochemistry, or similar); will consider non-degreed relevant work experience in…