Description: Will issue and retrieve all lab, production manufacturing and shipping batch records per the production schedule, as well as all required Research Protocol, Machine Trial and Experimental Protocol batch records for production activities. Will ensure batch records are issued in a timely manner to allow for production activities start, specifically when label creation is involved.
Issues lot numbers per the production schedule.
Issues and retrieves all lab, production manufacturing and shipping batch records per the production schedule, as well as all required Research Protocol, Machine Trial and Experimental Protocol batch records for production activities.
Ensures batch records are issued in a timely manner to allow for production activities start, specifically when label creation is involved.
Scans all batch records into appropriate systems in a timely manner, as soon as the review process is complete by MQA.
Archive all batch records and associated documentation following site applicable archival SOPs.
Coordinate the 3rd party review of batch records and investigations.
Maintains proficiency in performance of all applicable Manufacturing/Quality, etc. SOPs for this area.
Ability to coordinate project activities with multiple groups and individuals.
Ability to work independently with minimum supervision
Must be able to prioritize tasks and resolve routine issues.
Any other duties assigned by management.
W2 ONLY!!!! NO CORP TO CORP!!!
High school diploma or GED required, Associates degree or higher preferred.
Experience working with general office equipment.
2 + years of administrative office experience.
Knowledge of medical device quality systems include FDA, GMP & ISO.
Demonstrated ability to operate independently, with initiative and good business judgment.
Knowledge or Oracle and computer systems used in product development and manufacturing.
Proficient in Microsoft Excel, Microsoft Word & Adobe Acrobat and including scanners.
Must have experience working in a fast paced environment.
Ability to lift 50 lbs.
2 + years of Document Control experience within the Medical Device Industry preferred.
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Job ID: 18-00076
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