Quality Assurance Specialist

About the role

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.

Responsibilities

• 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.
• 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.
• Care for 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.
• Aid 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.
• Aid 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.
• Aid 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 meeting set goals.
• Handle customer communication as necessary.
• Complete special assignments and prepare reports/project summaries, as required.
• Perform additional duties/tasks as needed or requested by management.

Qualifications

• Minimum 5 years of Quality Assurance and ISO Quality System experience.
• Relevant experience may be leveraged.
• Strong analysis and problem-solving skills, including, but not limited to, the ability to review and analyze Manufacturing, Quality Control, and validation data.
• Demonstrated FDA cGMP knowledge for medical devices. Pharmaceutical knowledge a plus.
• Understanding of current ISO 13485 and supporting ISO standard requirements.
• Demonstrated knowledge of system auditing techniques and requirements.
• Demonstrated knowledge of FDA’s complaint handling requirements.
• Demonstrated knowledge of Clinical and Biological Evaluation standards/requirements.
• Leadership/mentoring skills.
• Strong decision-making skills.
• Exceptional interpersonal skills-ability to interface and communicate/collaborate at all levels internally and externally.
• Excellent writing skills.
• Exceptional project management and organizational skills.
• Excellent time-management skills and deadline driven.
• High attention to detail.
• Proficiency in Microsoft Office applications (Outlook, Excel, Word, PowerPoint).
• MasterControl a plus.
• Bachelor’s degree in a technical field (chemistry, biology, biochemistry, or similar); will consider non-degreed relevant work experience in quality, regulatory, or related field.
• ISO Quality System Training.
• Internal Auditor Training.

Desired Skills

• MasterControl a plus.

Benefits and Perks

Weekly Pay
Comprehensive Health Coverage - Medical, Dental & Vision Plans
Flexible Spending Accounts (FSA) – Medical & Dependent Care or Health Savings Account (HSA) Options
Company-Paid Life Insurance + Additional Voluntary Options
401(k) Retirement Plan with 3% Employer Contribution (after 1 year)
Fitness Benefits - Onsite Gym (Headquarters) or Membership Reimbursement (other sites)
Paid Time Off & Holidays to support work-life balance
Employee Assistance Program (EAP) for confidential support
Financial Wellness Resources
Employee Discounts & Perks (Eagles games, concert tickets, etc.)
Company Social Events & Team Activities
Career Development Opportunities & Internal Growth