Sr. Quality Assurance Specialist

Job Summary

BASIC SUMMARY:
Responsible for performing basic to highly complex auditing as it relates to validation, vendors, internal facility programs and process audits and providing regulatory support for training and client visits as well auditing of all study designs and data associated with a study to assure compliance with the applicable Good Manufacturing Practice Regulations (GMP) and laboratory Standard Operating Procedures (SOP). Responsible for recommending best practices, developing Quality Assurance auditing efficiencies, solutions, documentation and liaising with all relevant stakeholders.

ESSENITAL DUTIES AND RESPONSIBILITIES:

• Perform and/or oversee internal facility inspections at planned intervals to evaluate effective control and maintenance of site quality systems.
• Perform and/or oversee internal process audits at planned intervals to evaluate effective control and maintenance of site quality systems.
• Develop and/or participate in the development of site facility and process-based inspection schedules.
• Perform and/or oversee vendor audits at planned intervals to evaluate effective control and maintenance of site quality systems.
• Develop, manage, and/or provide training to QA Auditors.
• Oversee and/or participate in site GMP training program.
• Perform and/or oversee auditing of validation packages.
• Host and oversee all aspects of QA client visits.
• Host or provide support for all aspects of regulatory/monitoring authority inspections.
• Provide recommendations to Testing Facility and Quality Management for improvements of Quality Systems based on extensive knowledge and understanding of current regulatory inspection guidance and internal trends
• Participation in site or multi-site QRM projects to ensure robust and value-added approach to facility and process inspection programs.
• Perform the review and updating of departmental SOPs to reflect current practices
• Take lead role in coordination of QA projects.
• Ensure Data Integrity standards are effectively monitored.
• Lead and participate in cross-site auditing support of quality system functions.
• Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols, and corporate policies and procedures.
• Review/approve SOPs, protocols reports, and other quality and regulated records involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.
• Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management.
• Act as the technical QA subject matter expert, consult with operations site leadership and mentor more junior auditors.
• Review QA auditing, vendor management, and quality systems practices to identify efficiencies and make recommendations to leadership
• Perform all other related duties as assigned.

Job Qualifications

QUALIFICATIONS:

• Education: Bachelor’s degree (B.S. /B.A.) or equivalent, preferably in a life science, Master’s degree is preferred.
• Experience: Minimum of 12 years in a Quality Assurance role preferably in the life sciences field.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certifications/Licensure: Not required but desirable
• Other: Experience with Microsoft Office® applications and spreadsheet/database programs such as Access and Excel. Position requires the individual to be able to communicate clearly, effectively and professionally; easily grasp instructions without follow-up; attention to detail and strong writing skills are essential. The ability to work independently and manage multiple projects is required.

PHYSICAL DEMANDS:

• Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.
• Must regularly communicate with employees/customers; must be able to exchange accurate information.
• Must occasionally move about inside the office to access file cabinets, office machinery, etc.
• May occasionally be required to wear protective clothing and equipment.

WORK ENVIRONMENT: 

• General office working conditions and/or laboratory/manufacturing areas.
• The noise level in the work environment ranges from low to moderate.
• May occasionally be required to work in tight or confined spaces.
• May occasionally be exposed to high temperatures and humidity.

COMMENTS:

• May require occasional domestic and/or international travel (up to 30%).

Compensation Data

The pay range for this position is $93,000/yr - $110,000/yr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Competencies