Quality Assurance Coordinator
About The Position
This role is responsible for ensuring the quality and safety of products within the Animal Safety Manufacturing Operations. The Quality Assurance Coordinator will perform various auditing, tracking, documentation, and inspection tasks to maintain compliance with quality standards and regulatory requirements. The position involves working with mathematical concepts, statistical analysis, and computer software to manage quality metrics and documentation. The role also requires interaction with regulatory agencies and internal stakeholders, and may involve travel for industry seminars.
Requirements
- High school diploma
- Two years related experience and a clear understanding of quality assurance
- Ability to read, analyze and interpret common regulatory documents
- Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community
- Ability to effectively present information to management and public groups
- Ability to work with mathematical concepts such as probability and statistical inference and fundamentals of scientific analysis such as mean, median, mode, coefficient of variation and standard deviation
- Direct experience with Windows-based computers, use of personal computer, keyboard and software packages including; Windows, Microsoft Office, and Solomon
- Ability to define problems, collect data, establish facts, and draw valid conclusions
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with abstract and concrete variables
- Must have a valid driver’s license
Responsibilities
- Auditing batch records and manufacturing procedures
- Tracking of quality metrics associated with manufacturing operations or other areas as deemed necessary by the organization
- Assisting in ISO audits
- Assisting or conducting internal audits, as necessary
- Assisting with/writing of standard operating procedures (SOP) and forms related to the Animal Safety Manufacturing Operations
- Maintaining control of the Master Document List including all Master Batch Records and SOPs
- Assisting with/issue all documents, SOPs, and forms as needed
- Maintaining all records associated with operations including, but not limited to, completed batch records, on-site training records, completed validations, equipment calibration records, completed equipment qualification records
- Inspecting and releasing of all raw materials, including labels, inserts, components, containers and closures
- Inspecting and releasing of finished goods or disposition of non-conforming material
- Maintaining the records associated with deviations or non-conformances and the associated investigations, actions, and follow ups
- Sampling raw materials and initiate testing with laboratories
- Assisting with the sampling of finished goods and delivery to the appropriate laboratory (ies) for testing
- Assisting in maintaining stability programs
- Assisting in physical inventories
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
