Quality Assurance Technician - Brookings, United States - Medgene Labs

Description

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 ProviderTM for leading livestock producers and their veterinarians.

POSITION SUMMARY

Medgene Labs seeks a Quality Assurance Technician, who is responsible for Quality Assurance functions for a veterinary vaccine production company. The successful candidate will be responsible for developing, improving, and adhering to quality assurance goals and systems, including prioritization, and providing quality oversight for a manufacturing facility. This position will report to the Quality Assurance Manager. Professional and experienced in handling a wide range of Quality Assurance responsibilities. Able to work independently with little or no supervision.

JOB DUTIES

The Quality Assurance Technician, 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
• Provide document support to team members who produce batches and serials releases.
• Perform production batch and serial releases.
• Generation and quality approval of deviation investigation and auditing records
• Review of regulatory documentation such as Outlines of Production, Special Outlines, and labels.
• Communicate between departments to ensure projects are started, executed, and finished according to regulations and company policies.
• Coordinate with Regulations regarding facility documentation and equipment to ensure compliance.
• Support the document management system related to manufacturing.
• Auditing functions of facilities, processes, and inventories as prescribed
• Review of internal Master Documents
• Process improvement
• Management of the internal training program
• Management and internal release of raw materials
• Assist in internal and external audits.
• Organization
• Manage regulated labels including production and inventory.
• Support Manufacturing in the movement of products through computer systems
• Provide support in Quality Assurance activities such as Change Controls, Deviations, and Document Management
• Develop and implement workflows and processes.
• Manage the internal inventory system of inputs and final products.
• Review end-user records for the accuracy of implemented operations
• Training and Support
• Conduct a review of the adequacy and effectiveness of the Quality Management System
• Support and encourage a Quality Culture.
• Create, monitor, and train internal processes.
• Perform additional duties as required.

MINIMUM QUALIFICATIONS:

Knowledge of:

• Interest in vaccine licensing practices and procedures
• Interest in science and biotechnology
• Proven office management, administrative, or assistant experience
• Knowledge of office management responsibilities, systems, and procedures
• Excellent time management skills and ability to multi-task and prioritize work.
• Attention to detail and problem-solving skills.
• Excellent written and verbal communication skills
• Strong organizational and planning skills
• Proficient in MS Office
• Knowledge of data and administrative management practices and procedures
• Knowledge of clerical practices and procedures

Ability to:

• Follow detailed directions and instructions.
• Communicate information clearly and concisely.
• Establish and maintain effective relationships with coworkers.