Quality Assurance Manager

COMPANY DESCRIPTION

Medgene Labs helps veterinarians and producers protect livestock with precisely constructed immunological products and services. Applying a strategy of continual diagnostic surveillance and data analytics to the practice of immunology, creating vaccines for the disease at hand quicker and more precisely than previously possible. Medgene Labs has a single mission: To be a world-class Immunological Services Provider™ for leading livestock producers and their veterinarians.

POSITION SUMMARY

Medgene Labs seeks a Quality Assurance Manager, who is responsible for overseeing and approving internal Quality Assurance functions for a veterinary vaccine production company. The successful candidate will be responsible for developing, implementing, and maintaining quality assurance goals and systems, including prioritization, and providing quality oversight for the manufacturing facility. This position will report to the Quality Assurance and Regulatory Director. Professional and experienced in handling a wide range of Quality Assurance responsibilities. Able to work independently and in a team environment to meet company objectives.

JOB DUTIES

The Quality Assurance Manager, as a member of the Compliance Team, is responsible for ensuring quality assurance by ensuring processes and personnel activities are compliant with company policy and governing regulations.

• Operations
  • Responsible for measuring and monitoring compliance through audits.
  • Provides approval of batch records and other departmental documentation
  • Generation and quality approval of investigation records
  • Review of regulatory documentation such as labels, Outlines of Production, and Special Outlines
  • Responsible and accountable for all Quality oversight activities pertaining to regulated activities
  • Provide Quality oversight to SOPs, equipment inventories, and review/audit of other required activities.

• • Develop, implement, and maintain a Quality Management System (QMS) that supports the execution of vaccine production. This includes a high-level quality program for the implementation of processes, followed by quality system SOPs, forms, and other documentation reporting activities.
  • Assess team member workload and adjust to regulatory changes.
  • Quarterly and annual assessment of team objectives
  • Perform and assist in company and regulatory audits.
• Organization
  • Build Quality Assurance Team
  • Oversee and direct the Quality Assurance Team
  • Monitor Quality Management System and identify Gaps.
• Training and Support
  • Conduct a review of the adequacy and effectiveness of the Quality Management System
  • Support and encourage a Quality Culture and help ensure a safe working environment.
  • Analyze, monitor, and train internal processes.
• Perform additional duties as required.

MINIMUM QUALIFICATIONS:

Knowledge of:

• Advanced Knowledge of Quality Assurance practices and procedures
• Excellent time management skills and ability to prioritize work.
• Attention to detail and problem-solving skills.
• Strong written and verbal communication skills
• Strong organizational and planning skills
• Proficient in MS Office
• Computer skills and knowledge of office software packages
• Change agility

Ability to:

• Create and follow detailed directions and instructions.
• Communicate information clearly and concisely.
• Establish and maintain effective relationships with coworkers.
• Help provide solutions to improve quality culture.
• Organize and conduct small team and companywide meetings and training.
• Provide support to company departments with process development and improvement.
• Have critical conversations as they arise.