Job Title:

Technician I, Quality Operations

Department:

Quality Operations

Reports To:

Supervisor, Quality Operations

FLSA Status:

Non-Exempt  

Summary: QO Technician I perform a wide variety of activities to ensure the production operations follow internal procedures and applicable regulatory requirements such as Line Start-Up, In-Process verification. This job function will support various activities in production related to quality operations. 

Essential Duties and Responsibilities include the following:

• Perform work under cGMP environment.
• Perform Line Start-up for Packaging and Manufacturing Operations.
• Responsible for material labeling of finished goods, bulk product, intermediates, and raw materials.  
• Inspect incoming bulk and finished goods for further processing.
• Inspect outgoing Intermediates sent to Contract Manufactures.
• Perform facility walkthroughs and reports observations.
• Track and record temperature in the Retain Room and update the chart recorder paper.
• Assist with the collection of retain samples. Organize and maintain retain samples.
• Report findings to department management and provide feedback.
• May be required to perform other duties as assigned or as needed.

Supervisory Responsibilities:

None 

Qualifications: 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.

Education and/or Experience:

• High School diploma. 
• 1+ years of experience in GMP regulated environment.
• Equivalent combination of education and experience may apply.

Knowledge, Skills, and Abilities:

• Ability to effectively communicate verbally and in writing and work productively in a team-oriented environment.
• To perform this job successfully, an individual should have basic knowledge of Manufacturing, Spreadsheet, and Word Processing software.
• Good understanding and knowledge of cGMP, GLP and QA/QC processes and procedures.
• Ability and willingness to work late or on weekends if required.
• Ability to effectively communicate verbally and in writing and work productively in a team-oriented environment.

Physical Demands: 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 use hands to finger, handle, or feel; reach with hands and arms. The employee is frequently required to stand, walk, talk, and hear. The employee must regularly lift and/or move up to 10 pounds, and frequently lift and/or move up to 25 pounds.  

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing 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 frequently exposed to fumes or airborne particles. The employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually moderate.

This job description is subject to change at any time.