Quality Assurance Associate
- Carrying out Quality Inspection of all incoming batches including return goods per current approved procedure.
- Pull out data loggers from the batches, download the data, enter the temperature entries in SAP and generate Data logger Communication Form for each batch.
- Forward all DLC Forms to respective manufacturing sites for their review and disposition recommendation.
- Upon receipt of the disposition recommendation from the site, keep DLC forms/COA in batch/PR&D dedicated folder.
- Perform transportation studies per approved protocol.
- Support in investigations related to QA and warehouse operations.
- Handling of damaged, rejected, recalled drug product.
- Handling of destruction of pharmaceuticals drug products.
- Support regulatory inspections (FDA, DEA, VAWD/NABP, NJDOH etc.)
- Ensure US Allentown distribution warehouse is in compliance following CGMP’s.
- Handle/carry out other QA departmental activities/projects as assigned by supervisor.
- High School Diploma and equivalent
- Minimum 1 to 5 years of related experience in the pharmaceutical industry, preferably in QMS and Warehouse Quality compliance.
- Excellent communication skills, both written and verbal
- Knowledge of Pharmaceuticals Warehouse activity will be preferred
- Knowledge of GMP and regulatory requirements for the pharmaceutical industry.
- Strong proficiency with applicable computer software, SAP and MS applications.
- The incumbent typically works in an office environment and uses a computer, telephone and other office equipment as needed to perform duties.
- The noise level in the work environment is typical of that of an office.
- Incumbent may encounter frequent interruptions throughout the workday.
- The incumbent is regularly required to sit, talk, or hear; frequently required to use repetitive hand motion, handle or feel, and to stand, walk, reach, bend or lift up to 20 pounds.
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