Quality Technician (7am-7pm)

Sharp Packaging Services • Allentown, PA

1d • Onsite

About The Position

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.

Requirements

• Detailed oriented
• 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.

Nice To Haves

• An associate or bachelor’s degree is preferred

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.
• Responsible for notifying supervision if any abnormal occurrences are observed while performing job responsibilities.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree