? Responsible for the process of document control, including managing drafts, editing, approval, change control, distribution and archiving, of all controlled documents (e.g. Standard Operating Procedures (SOPs), Batch Production Records, Stability Protocols, Qualification Protocols, Specifications, Equipment Records, etc). ? Maintains, enhances, and serves as local administrator for training curriculum database (ComplianceWire ) and associated paper training records. ? Manages and distributes SOPs and other controlled documents. ? Performs filing, scanning, maintenance, and organization of controlled documents. ? Assists with document retrieval during customer audits. ? Performs other related quality tasks as assigned, which may include data review ? Other duties as assigned. Hours: Location: 114 726 Heartland Trail Madison WI 53717 United States Education: Additional Job Details: SHIFT CAN BE FLEXIBLE - PLEASE INDICATE YOUR CANDIDATES DESIRED SHIFT AT TOP OF RESUME. Work Environment: cubical, fast paced, more on the quite side Term/Length: 6 months with possibility of extension Job Details: currently using a software system that is very manual - data entry ? that has lots of errors so moving to new software system. This position will be supporting the new software implementation Will be ensuring data is clean before moving to the new systems. This department handles all the systems for the QA program along with oversight of all equipment management. Such as calibration working correctly and ensuring that all systems are functioning accurately. A successful candidate will be detail oriented with strong data entry skills. A background in data entry or equipment management, meteorologist, equipment specialist would be a big plus. QA background not required - can be trained. Pharma or manufacturing background also a huge plus. Must be comfortable learning new software. Education Requirements: Min 2 year associate with 2 years exp; if no higher education candidate must have solid work history in related field. Experience Requirements: Excel, MS Office, JD Edwards software esp a plus, Blue Mountain exp also a plus Top 3-5 requirements: Detail oriented , fast learner, intermediate computer skills Job Qualifications Minimum Requirements:
? Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science; or Associate's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science. ? Minimum of two years' related experience. ? Ability to use Excel, Word, and other office systems. ? Ability to understand and independently apply GMPs to everyday work with regard to documentation and review. ? Ability to apply applicable regulatory authority and guidelines with training. ? Demonstrates theoretical understanding of the work tasks assigned. ? Ability to operate within a clean room environment as needed. ? Maintain high quality documentation in accordance with applicable regulatory guidance and Site SOPs. Ability to learn and use quality management software (e.g. TrackWise , ComplianceWire ). ? Ability to learn and retain technical information. ? Executes routine procedures and process with high quality. ? Ability to operate assigned office equipment. ? Ability to complete investigation, deviation, and change control forms with initial consultation from supervisor as needed ? Capable of learning of unfamiliar principles or techniques with training. ? Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form. ? Edits Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and reports independently and accurately. Associated topics: performance test, prevent, prevention, qa, quality, quality assurance, quality assurance analyst, software quality, software quality assurance, test
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.