Quality Assurance Coordinator

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Auditing batch records and manufacturing procedures
• Tracking of quality metrics associated with manufacturing operations or other areas as deemed necessary by the organization
• 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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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. Computer used in 50% of job activities.

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.

Expected to attend industry and training seminars related to position. These seminars may require overnight travel.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; and talk or hear. The employee is required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl.

The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25…