Quality Technician (7am-7pm)

SUMMARY:

The role of the Quality Technician is to ensure GMP compliance throughout the execution of labeling, assembly, and packaging activities.

The Quality Technician is responsible for supporting Operational activities that directly impact manufacturing.  The primary activities include performing line clearance verifications, adjustment of AQL sampling quantities, completing real-time and end of batch review of documentation such as batch records and logbooks, and taking Finished Good and Special Request samples as required throughout the labeling, assembly, and packaging processes.

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

The following is a list of minimum responsibilities required of the Quality Technician position. Other duties may also be assigned.

• Ensure all batch record documentation is accurate (lot numbers, expiration dates, items number and related data are consistent throughout the record; AQL Report is accurate), and complete.
• Read and understand process steps within the batch record to ensure compliance during the packaging process.
• Review batch records for any additional requests, memos, deviations, change controls, material request transfer forms, etc. and ensure appropriate actions are taken.
• Ensure room/equipment cleaning logs have been completed as applicable.
• Pull all Finished Good (Reference, Retain and Reserve) and special request samples as required in batch record and material request transfer forms
• Support operations by completing line clearance verifications after room clean activities.
• Responsible for notifying supervision if any abnormal occurrences are observed while performing job responsibilities.

QUALIFICATIONS:

To perform this job successfully, the candidate must be detailed oriented.  The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• One (1) year of related pharmaceutical experience or training.
• General knowledge of FDA regulations related to cGMPs is required.
• General knowledge of quality control/assurance is required.
• Strong written and verbal communication skills are required.
• Strong foundation in basic mathematical skills (addition, subtraction, multiplication, and division)
• Strong problem solving and critical thinking skills.
• Strong organizational and planning skills are required.Top of FormBottom of Form

SUPERVISORY RESPONSIBILITIES:

This position will have no supervisory responsibilities.

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:

An associate or bachelor’s degree is preferred

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 accommodation 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, stand, walk and use hands to finger, handle, or feel. The employee is occasionally required to reach with hands and arms. The employee must occasionally lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, and color vision.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is normally exposed to moving mechanical parts.  The noise level in the work environment is usually moderate.

DISCLAIMER:

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.