Quality Technician (7am-7pm)

About the role

The Quality Technician is responsible for supporting Operational activities that directly impact manufacturing by ensuring GMP compliance throughout the execution of labeling, assembly, and packaging activities. 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.

Responsibilities

• 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
• Notify supervision if any abnormal occurrences are observed while performing job responsibilities

Qualifications

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

Preferred education and experience

• Associate or bachelor's degree preferred

Physical demands

• Regularly required to sit, stand, walk and use hands to finger, handle, or feel
• Occasionally required to reach with hands and arms
• Must occasionally lift and/or move up to 35 pounds
• Specific vision abilities required include close vision and color vision

Work environment

• Normally exposed to moving mechanical parts
• Noise level is usually moderate