Senior Quality Assurance Officer – onsite

hive + co; Columbus (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

hive + co in Columbus, Ohio seeks a Senior Quality Assurance Officer to lead QA within the CBRNE laboratory division. You will train staff, manage audits, and communicate with the Quality Manager to ensure compliance with government regulations and client standards.

Responsibilities include corrective action planning, root-cause analysis, and development of QA policies to reflect changing regulations and client requirements.

Qualifications

• Bachelor’s degree in a related field with 8+ years’ QA leadership in a lab/regulated environment.
• Experience with ISO 17025 and regulatory practices.
• Ability to obtain a top secret clearance.

Responsibilities

• Lead QA within the CBRNE laboratory business, including training and audit management.
• Review nonconformities and drive corrective actions with management.
• Develop QA policies and procedures reflecting regulatory changes and client policy.

Skills

Leadership

Auditing

Regulatory compliance

Clearance (Top Secret)

Education

Bachelor’s Degree in related field

Job description

Columbus, Ohio client has a direct hire opportunity for a Senior Quality Assurance Officer who will act as lead for Quality Assurance within the Chemical, Biological, Radiological, Nuclear, and Energetics (CBRNE) laboratory business, including training, audit management, and assignments, and timely communications with Quality Manager. Guides QA staff and determines if the work conducted and the products generated comply with client’s standards of quality as defined by Government regulations, client specifications, and internal policies.

Responsibilities

• Reviews and determines the appropriate corrective action for areas of noncompliance, and either implements these actions or makes recommendations to management for complex issues that require extensive knowledge and experience.
• Facilitates causal analysis to identify root causes, develops action plans, oversees the implementation of corrective and preventive actions, and verifies the effectiveness of these corrective measures.
• Collaborates with management to develop research proposals, ensuring a thorough understanding of interested party requirements and execution risks. Identifies gaps in quality management system controls and drives process development and improvement to meet applicable requirements. Provides quality assurance cost estimates for planned work.
• Collaborates with management to develops quality assurance policies and procedures to reflect changes in industry- or government-related regulations and client policy.
• Develops and executes quality assurance plans in an analytical lab setting, applying appropriate measures, metrics, and management controls with the goal of guiding flawless project execution and delivery.
• Provides mentoring to junior quality assurance staff and may develop and conduct quality assurance training programs. Maintains comprehensive knowledge of all relevant regulations, as well as current client and department policies.
• In coordination with Quality management, assigns new studies to auditors, ensuring workloads are balanced and that inspections are completed at their respective sites.
• Conducts work within prescribed budgets or consults with management before proceeding with tasks.
• Oversee junior staff on projects ensuring budgets are met.
• Performs validation audits of equipment and systems, conducts internal facility inspections for compliance with all stated requirements, and completes peer reviews of audits.
• Provides guidance to auditors and conducts routine, non-routine, or focused internal quality assurance audits or inspections as necessary or required. Performs or assists Manager on inspections/audits performed by clients and/or regulatory agencies.
• Reviews subcontracted services on site to ensure experimental procedures are being followed.
• Reviews project operations to confirm adherence to experimental procedures.
• Prepares written reports of audit and inspection findings for management and ensures that appropriate corrective actions are taken.

Key Qualifications

• Bachelor’s Degree in a related field; 8 years of experience in a quality assurance program applied to laboratory operations including use of analytical equipment, and proven leadership skills
• Experience with ISO 17025
• Must have working knowledge of regulatory practices and other guidance documents.
• Must be able to obtain a top secret clearance

Preferred Qualifications

• Knowledge of client policies and procedures.
• Experience participating on committees both internal and external to the organization to provide a quality perspective on continual improvement processes.
• Certified auditor (i.e. ASQ Certified Quality Auditor, ISO 9001:2015 Certified Auditor, etc).
• Experience supporting a variety of quality programs

Reference:1065914

Worried that you don’t meet every single requirement listed in the job ad? Studies have shown that individuals from marginalized groups are less likely to apply to jobs unless they meet every single qualification. Hive + Co. is dedicated to building a diverse, inclusive and representative workplace, so if you’re excited about this role, but worried that you don’t meet every requirement, we encourage you to apply anyways. We’d love to get to know you.