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Quality Assurance Lead
Location:
Brookings, SD
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. Medgene is seeking to hire a Quality Assurance Lead for our rapidly growing business and product pipeline. Purpose: The Quality Assurance Lead, as a member of the Operations and Quality Team, is Responsible for managing quality assurance by ensuring processes and personnel activities are compliant with company policy and governing regulations. Distinguishing Feature: The Quality Assurance Lead must demonstrate competency and requires a high degree of independent judgement. Functions: Operations Provide batch release support and approval for serials Generation and quality approval of investigation records Review of regulatory documentation such as Outlines of Production and Special Outlines Coordinate with Regulatory regarding facility documentation to ensure compliance Support the SOP management system as related to manufacturing Deviation and CAPA processes including investigations and documentation Auditing functions of facilities, process and inventories as prescribed Organization Manage regulated label including release and inventory Manage program to maintain calibrated and validated equipment Maintain and support chemical inventories, status, and release Manage internal inventory system of inputs and final product Training and Support Conduct review of 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 Contact with Others: Daily contact with all staff. Working Conditions: Standard office setting. Knowledge, Skills, and Abilities: 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 Ability to: Create and follow detailed directions and instructions Communicate information clearly and concisely Establish and maintain effective relationships with coworkers Reporting Relationships: Reports to Compliance and Regulatory Manager . No supervisory relationship. Challenges and Problems: Challenges include wide range of Quality Assurance related needs. Accountability and level of Impact Local project team member; completes specific assignments that directly impact group/project team Requires minimal supervision Technical/Functional Expertise & Application Applies knowledge in a broad area of office processes and techniques. Modifies existing local processes and procedures in area of training, on a limited basis, as needed. Will provide training to others. Performs tasks executes respective action plans. Problem Solving and Innovation Makes routine decisions and applies creativity to resolving routine and non-routine problems associated with project team work Communication, Collaboration and People Influence Collaborates and proactively shares information with local associates and project team(s). Demonstrates respect for, and inclusion of, diverse ideas and perspectives Documents own and team's work; presents in small groups Job Posted by ApplicantPro
Company:
Medgene Labs
Posted:
January 25 on ApplicantList
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More About this Listing: Quality Assurance Lead
Quality Assurance Lead is a Quality Assurance QA Job at Medgene Labs located in Brookings SD. Find other listings like Quality Assurance Lead by searching Oodle for Quality Assurance QA Jobs.
Quality Assurance Lead is a Quality Assurance QA Job at Medgene Labs located in Brookings SD. Find other listings like Quality Assurance Lead by searching Oodle for Quality Assurance QA Jobs.