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.
- Records management experience is a plus.
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Since our inception in 1999, Townsend and Associates aims to be the staffing firm both clients and professionals turn to first. Our core competencies in project staffing and full time placements are being continuously improved to be the best in class. Our markets will be solely determined by our ability to consistently deliver unequalled service to our customers and candidates.
Staffing your company with qualified and talented professionals is both challenging and time-consuming. Our goal is to make sure we understand your needs and the needs of our candidates. We research, screen and interview our consultants and employees, so we can provide you with the industries finest talent. This is why more and more companies decide to partner with Townsend & Associates, Inc.
Townsend & Associates, Inc. offers you the opportunity to work with Fortune 1000, small and medium companies for full-time or contract positions. We work together with you and our clients to create an ideal match. We discuss your career objectives, talent, experience, and what you are looking for in a new job.
Our screening research is 2nd to none. By being thorough and straight forward, we cut through a lot of challenges that arise in many job searches. So whether it’s full-time or a contract position let Townsend & Associates simplify and enhance your journey. Not Ready To Apply?
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