Quality Assurance Associate

Job Title: Stability Technician/ Quality Assurance Associate III

Location: Chattanooga, TN

Duration: 12 months contract (Possible Extension)

Note:

Education: A.S. Degree in Chemistry or closely related field.

Experience: 3 years of GMP related experience or equivalent.

Professional Skills: Basic computer skills, technical writing skills, attention to detail, and good communication skills.

Role Specific Competencies: Knowledge of GMPs. Heavy Data Entry. This position requires extensive use of computer equipment. Must have a demonstrated proficiency in Microsoft business software including Access, Excel, Word, and Outlook.

Job Description:

Job Title: Stability Technician/ Quality Assurance Associate III

Department: Quality Assurance

Job Summary

This contract position is responsible for various aspects of support for the Stability program including the organization of samples and documentation related to the room temperature stability program. This position will be guided on support-related tasks such as retaining sample data entry, APR database data entry, sample labeling, and sample collection and delivery. In addition, this position also supports any duties of the Stability Technician II and the Stability Data Analyst II roles as needed.

Role Specific Responsibilities

Stability Technician duties fall under the Product of any data or documentation that relates to the room temperature stability or accelerated stability process.

Labeling, storage and organization of room-temperature or accelerated stability samples and documentation.

Enter and/or verify analytical and water data in the APR database.

Enter and/or verify stability data in Novatek.

Provide support for the file sample process by logging samples in SAP.

Filling of room temperature stability results.

Logging of samples for the laboratory.

Perform visual inspection of retain samples.

Supports Stability Technician II and Stability Data Analyst II with other department related duties as assigned (e.g. – lab clean up)

Interfaces

Quality Assurance

Quality Control (Analytical and Microbiology)

CHC Research and Development

Analytical Research and Development

Analytical Quality Assurance

Complaints

Competencies

Must be organized and detail oriented

Project management

Technical writing

Statistical Analysis

Ability to adapt to a changing environment and adjust flexibly

Strong verbal and written communication skills required

This description is representative but not inclusive of all position responsibilities. Associate may be asked to complete tasks not listed within the contents of this document, but that are relative to the goals of the business.