Quality Assurance Specialist

SUMMARY:

 There are three positions opened with three different specialties. 

• QA Specialist (IVD)- Successful candidates will have prior experience in the development, submission, and approval process for NYS LDTs and FDA IVDs. Candidates should have prior experience utilizing Design Control for assay development. They will also have had prior experience participating and completing validations applicable to a clinical laboratory. ASQ certified Supplier Quality Professional individuals are highly desirable.
• QA Specialist (Supplier Management & Audit Program)- Successful candidates will have prior experience managing a supplier management program (conducting prequalification/requalification/ for-cause audits & successful document management). Successful candidates will have prior experience preparing a cross-functional team for and hosting client audits and regulatory inspections (CAP, NYS) as well as conducting internal audits. Certified Quality Auditors (ASQ) with prior FDA inspection experience are highly desirable.
• QA Specialist (Safety Program)- Successful candidates will have prior experience managing a training program (development, administration, and record management), conducting routine safety inspections in a clinical laboratory, as well as developing and maintaining safety policies and procedures to meet regulatory requirements.

QUALIFICATIONS:

• Education:
• Master’s degree with 2 years of quality experience in a clinical laboratory setting or equivalent combination of experience.

• Bachelor’s degree with 4 years of quality experience in a clinical laboratory setting or equivalent combination of experience.

• Associate’s degree with 6 years of quality experience in a clinical laboratory setting or equivalent combination of experience.

• Certification:
• ASCP Technologist Preferred
• ASQ/RAPS/SQA certification Preferred
• Experience:
• In-depth knowledge of CLIA, CAP, NYS standards and regulations
• Experience with ISO15189 and 13485, preferred.

• Poses fundamental understanding of clinical and/ or laboratory testing.
• Experience writing, reviewing and editing SOPs, as well as other document types
• Ability to work in a collaborative team environment, with a customer-focused approach
• Proficient in Microsoft Office (MSWord, Excel, Outlook, PowerPoint, Smartsheet, SharePoint)

• Works independently, organized, self-motivated, and results oriented

DUTIES AND RESPONSIBILITIES:

• Assist in maintaining established quality systems and continuous improvement activities through the generation and revision of controlled documentation and the oversight of change and design control.

• Participate in defining a road map of continuous improvement for the organization by establishing priorities, methods and strategies for implementation using data to both guide the process as well as monitor the result.

• Partner with stakeholders on thorough documentation, root cause analysis and resolution of quality system events including nonconformances, customer complaints, SCARS, safety incidents, and CAPAs.

• Identify risks or roadblocks to management; raise critical issues in a timely manner.
• Support validation activities, including review of validation protocols, reports, and design control documentation
• Review risk management documentation and actions for completeness, feasibility and adequacy. Track mitigation efforts to reduce medium and high risks to acceptable levels.
• Represents QM as Validation SPOC (Single Point of Contact) for Facility Equipment and systems, Computerized Systems, Laboratory systems and participate on SOP authoring/review and implementation to site. Reviews validation strategy and plans for the site.
• Act as SME (Subject Matter Experts) to develop validation and qualification procedures, train and guide site personnel in validation area including guidance on audit preparations or leading investigations whenever required.
• Assist in scheduling, preparing, performing, and reporting internal audits, as well as other related activities.
• Perform reference lab or vendor/supplier audits, issue audit reports, and follow up to close out actions which address the findings and other associated activities
• Assist in scheduling and preparation activities for external audits and inspections. Management of backroom activities during audits and inspections. Including retrieving and reviewing requested documentation and records, and assistance in preparing subject matter experts for audit/inspection interview
• Assist in maintaining established BG Safety Program by conducting facility inspections, resolving findings with stakeholders and revising documentation to align with best practices and regulatory requirements
• Generate, maintain, and analyze quality metrics for presentation and review during quality management review meetings
• Ensure the laboratory remains in compliance with applicable regulations, guidance, and/or standards by maintaining current awareness of regulatory requirements and their changes
• Support regulatory activities and requests for information as needed for filings, marketing applications, etc.

• Adheres to Code of Conduct as outlined in the Baylor Genetics Compliance Program
• Performs other job-related duties as assigned.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

• Frequently required to sit
• Frequently required to stand
• Frequently required to utilize hand and finger dexterity
• Frequently required to talk or hear
• Frequently required to utilize visual acuity to operate equipment, read technical information, and/or use a keyboard
• Occasionally exposed to bloodborne and airborne pathogens or infectious materials

EEO Statement: