The Quality Control/ Assurance Specialist will generate an inspection summary report recommending whether a warning letter is warranted and support retailer responses. Will create case in management system. Primary role will be to review data submitted by inspectors for completeness, consistency and accuracy, review the data for possible violations.
|Essential Duties:||These activities consist of: • Use FDA software system to resolve and handle review of tobacco information. • Knowledge and experience in data entry in accordance with the FDA instructions, including quality control and quality assurance procedures to ensure appropriate selection. • Perform such tasks as using FDA terminology to code reports from forms or images of these forms into an FDA database. • Verify and perform data entry. • Review and retrieve system data, match output with specifications in accordance with the Standard Operating Procedures and resolve discrepancies. • Assist in the development of Standard Operating Procedures. • Assist lower level personnel in task activities. • Perform quality assurance on data entered into the FDA system. • Provide feedback regarding quality of work and deficiencies to data entry staff. • Resolve problems related to data entered by the personnel into the database. • Knowledge and ability in performing database and internet searches.|
|Requirements:||• Must have experience analyzing reports • Attention to detail|
|Skill:||• Excellent verbal and written communication • Strong interpersonal skills with demonstrated ability to partner and build relationships with managers, employees and third-party associates|