Quality Assurance Specialist - Genus PLC

Role Overview:

Genus PLC has an exciting opportunity. We are looking for a Quality Assurance Specialist to oversee the quality management systems for development and commercial production of animals derived from biotechnology. The position is located in either our DeForest or Waunakee offices and hybrid work is an option. The Quality Assurance Specialist must have full knowledge of required specifications for quality, function, reliability and relevant regulations and has primary accountability for ensuring products meet the required specifications prior to delivery.

You Will:

• Develops, implements, and manages company quality management system (QMS) for development and commercial production of animals derived from biotechnology.
• Lead all aspects of compliance, quality control and stewardship through the discovery, development, launch and post approval stages of Genus products
• Reviews and approves QMS-related activities such as SOP review and revision, staff training, document control, and creation of required reporting.
• Collaborate with R&D and product development teams to develop, maintain and enhance compliance capabilities and relationships to support Genus’ product pipeline.
• Conducts periodic facility inspections and record audits of regulated analytical laboratories and production barns and determines compliance.
• Serves as the primary point of contact and representative of the Company for FDA-CVM audits and facility inspections.
• Provides solutions and guidance on implementation of solutions for out-of-scope operational defects, drawing from established principles and direction of business.  
• Discerns and communicates quality standards and parameters to R&D team, product development team, and other appropriate staff. 
• Collaborates with Senior Director of Regulatory Affairs to develop and implement regulatory compliance standards.

Requirements:

Basic Qualifications: (required)

• University degree in Animal Sciences, Plant Sciences, Life Sciences, Biology or Molecular Biology
• A minimum of 4 years of experience developing and operating a quality management system in life sciences - technology-driven company
• Demonstrated experience in project management and compliance with regulations
• Excellent organizational and interpersonal skills are required
• Ability to work both autonomously and collaborate across teams and functional areas
• Ability to work in and maintain performance expectations in diverse cultural contexts and fast-paced environment
• Work requires continual attention to detail and ability to establish priorities and meet deadlines
• Demonstrated ability to identify analyze and solve problems in an empowered, self-directed/managed work environment
• Proficient in Microsoft Office
• Ability to travel approximately 10-20%
• Authorized to work in the U.S. without sponsorship

 

 

Preferred Qualifications:

• Advanced degree (Animal Sciences, Plant Sciences, Life Sciences, Biology or Molecular Biology)
• Experience in animal husbandry or production a plus
• Six Sigma, Lean certification, or ISO certified or similar quality management certification a plus
• Prior experience with FDA-CVM, agricultural biotechnology regulations, or biological laboratory research a plus
• Knowledge of GLP/GMP standards, compliance and quality control measures required for biotechnology products

Business Overview:

Genus is an agricultural biotechnology pioneer. We are a global FTSE 250 company, headquartered in the UK, and listed on the London Stock Exchange.  Genus PLC has a presence in over 70 countries and a global workforce of over 3,000 employees and growing.  We are a worldwide leader in porcine and bovine animal genetics, partnering with farmers to transform how we nourish the world – a mission that is important to a sustainable future. 

 

Our vision is clear: Pioneering animal genetic improvement to help nourish the world.

Benefits Overview:

At Genus we offer a competitive salary. Benefits include health, dental, vision, FSA/HSA, long and short-term disability, 401K, tuition reimbursement, paid holidays and ETO (employee time off). This position will have opportunity for growth.

Equal Employment Opportunities:

Genus is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. Genus prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Genus conforms to the spirit as well as to the letter of all applicable laws and regulations.

Recruitment Fraud Warning:

Genus plc will never ask you to provide fees or payment for computer, software, or other equipment or supplies during the recruitment and/or onboarding process. If you have any questions about your individual application, please contact the Genus Talent Acquisition team at recruiting@genusplc.com.