Quality Assurance Associate

This position has the overall responsibility to evaluate and review laboratory, manufacturing, QA material release and all associated procedures to assure compliance with applicable and internal procedures and policies.

Education and experience

• Bachelor's degree in microbiology, biology, immunology or related life science, plus 3 years of related experience
• Prior experience related to research, licensing, and/or commercialization of biological products is strongly preferred

Technical skill requirements

• Knowledge and understanding of USDA regulations
• Self-starter with ability to work independently
• Good documentation skills
• Organized
• Keen attention to detail
• Keen attenion to due dates and deadlines to meet production schedules
• Basic understanding of the technology employed within production and the lab
• Ability to use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusion or approaches to problems
• Ability to communicate verbally and in writing to reinforce requirements in a positive and professional way to colleagues at all levels within the organization
• Ability to identify complex problems and review related information to develop and evaluate options and implement solutions
• Must have strong team participation skills and ability to communicate effectively with people and team members at all levels of the organization
• Be proficient in the use of MS Office software packages

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. The employee is occasionally exposed to a variety of extreme conditions. The noise level in the manufacturing environment can be loud. Ability to travel to Lincoln site on occasion.

Position responsibilities

• Monitoring production and laboratory activities to ensure compliance with SOPs, outlines of productions, and other applicable documents
• Scheduling and conducting internal audits of production, laboratory, facility and document control functions to ensure compliance with SOPs and appropriate regulations and follow up to ensure compliance issues are addressed
• Responsible for review and approval of production and testing records to ensure compliance to internal procedures and USDA approved documents for release of products for distribution
• Responsible for submission of APHIS Form 2008 on CVB portal for product release
• Reviewing standard operating procedures, specifications and other documentation for compliance to internal procedures and regulatory documents
• Responsible for QA release and disposition of raw materials in a timely manner
• Maintains current personal training on applicable documents and relevant procedures
• Responsible for notifying QA Manager, QA Lead and site management of delays that prevent timely review or of missed deadlines because of compliance issues
• May assist with the archival of laboratory and production generated raw data 
• Assist with Quality Systems training for employees
• Assist with deviations and investigations and recommendations and follow-up for corrective and preventative actions
• Assists personnel with compliance problem solving
• May participate in annual review or change control of approved regulatory documents

Competencies

• Communication
• Customer focus
• Integrity, safety and compliance
• Collaboration
• Achieves results
• Adaptability
• Initiative
• Quality orientation
• Written / oral communication
• Teamwork
• Critical thinking

How to apply

Using the form below, please send us your cover letter and CV in English, ensuring that your CV contains only information relevant to your academic and professional background. Please avoid sharing other sensitive personal data. Your application package will be treated with strict confidentiality. The personal data you provide will be treated in the strictest confidence in accordance with the applicable personal data protection legislation. Only shortlisted applicants will be contacted with information about the next steps of our selection process.