- 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.
- 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
- Follow detailed directions and instructions.
- Communicate information clearly and concisely.
- Establish and maintain effective relationships with coworkers.
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Quality Assurance Technician - Brookings, United States - Medgene Labs
Description
Job Description
Job DescriptionCOMPANY 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.
MINIMUM QUALIFICATIONS:
Knowledge of:
Ability to:
