Quality Assurance Specialist

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 Specialist
• Schedule:
  
  8:30 am - 5:00 pm, M-F, with some flexibility.
• Location:
  
  Gibbstown, NJ (08027) with requirements to work at another office in Cherry Hill, NJ weekly.
• Salary Range: $80,000 - $100,000 annually, based on experience and qualifications.

The Quality Assurance Specialist ensures products and processes adhere to relevant industry standards, regulations, and specifications by coordinating and supporting activities of the QA Team related to Keystone’s Quality Management System as identified below:

• Provide general guidance, and/or training to members of the team on Annual Product Reviews (APRs), Internal Audits, Change Management, Complaint Management, CAPA, deviation and Batch Card approval.
• When assigned, serve as the lead QA liaison for new project initiatives across new divisions, leading all related QA activities.
• Ensure all record requirements for project planning, design control, purchasing activities, customer complaints and other feedback, etc. are met.
• Define/clarify cGMP and ISO standard requirements 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 the Supplier Quality Management System. Work with other department members to qualify suppliers and perform continuous evaluation. Issue and manage supplier corrective action requests. Lead external (supplier) audits and complete associated reports.
• Maintain assigned quality system elements, including but not limited to the Internal Audit system, APRs, Customer Complaint Handling, Deviations, Non-Conformances, and CAPA systems. Participate in the completion, review and approval of the documents associated with these systems.
• Generate reports to update management on GMP Compliance status.
• Perform batch record reviews, ensure follow-up and resolution of any issues, and confirm that all documentation is completed and maintained accurately.
• 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.
• 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. Prepare or assist with Management Review Reports, Annual product Review Report, data presentation and ensure appropriate meeting minutes are recorded, and follow-up activities are performed and documented.
• Advise with project planning, design control and risk assessment responsibilities as necessary. Assist with risk analysis and product Post Market Surveillance activities as required.
• Help to update device tech files to meet new regulatory requirements.
• Assist with cleaning and process validation activities as needed.
• Inform Management of problems found within the quality system and updates on improvements or necessary corrective actions.
• Participate in external regulatory, customer and ISO Notified Body audits. Act as SME for QMS related activities. Help coordinate/document resulting corrective action closeout activities.
• Create, revise, and manage contractual quality agreements and standards with external partners.
• Support company goals/objectives and plans for…