3 Quality jobs

Regulatory/Quality Document Specialist Job #19-07A   Mapp Biopharmaceutical, Inc. is an innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases.  The Regulatory/Quality Document Specialist  is responsible for managing the logistics, preparation, maintenance of regulatory and quality documents in accordance with applicable guidelines and regulations.  The Specialist will also support generation and review of important Quality/Regulatory documents and will support the functional leads on projects involving document management/quality systems.  The Specialist will assist with management and authorship of SOPs and other duties as assigned. Basic Qualifications: BS in a relevant discipline is required Minimum of three (3) years experience providing Regulatory/Quality document management support Knowledge of the drug development paradigm for New Biological Entities Ability to mine the FDA.gov and OUS agency websites for pertinent regulations and background information Strong knowledge of Microsoft Office Suite and Adobe Acrobat Experienced and proficient with writing technical documents suitable to technical audiences (funding organizations, Regulatory agencies,  etc .) Demonstrated organizational skills, strong verbal and written communication skills, and attention to detail Ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities Experience with facilitation of efforts within a team from planning through to completion General awareness of Project Management tenets (scope, timeline, budget, risk) Preferred Qualifications: Knowledgeable in CTD/eCTD structure and requirements and firm understanding of submission requirements for US submission types ( g.  IND, PAS, NDA, PSUR,  etc. ) Familiarity with current regulatory submission standards and industry best practices preferred   Knowledge of Adobe Plug-Ins ( g.  ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools is an asset Responsibilities Files and maintains archives of regulatory communications and important quality documents Participates in the assembly of regulatory submissions for Mapp's development and commercial stage products Assists with Quality Management System projects Assists with downloading, verification of Mapp documents in electronic document control system Plans and establishes requirements for the Quality System in accordance with applicable regulations and standards Assists the organization in development, documentation and implementation of policies and procedures that define, implement and support the Quality System Participates in the gathering of scientific data, preclinical and clinical study reports, manufacturing and analytical data and reports, and other technical information to support regulatory submissions Assists and/or participates in the implementation, migration, and upgrade of regulatory systems, tools and templates Performs document management tasks including file transfer, storage, tracking, and archiving of Regulatory submission documentation Establishes and maintains Regulatory submission tracker and other trackers to assist team members in understanding upcoming workload Develops and administers in-house training, according to Quality/Regulatory and submission project team needs, to include training on authoring templates, processes and tools critical to Quality/Regulatory endeavors Participates in the writing and reviewing of Regulatory communication (SOP, Work Instructions and internal guidelines)  Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in Carmel, Indiana or may have the opportunity to work remotely.  Travel (~<5%) will be required for this position.  Mapp wants you to join their team and invites you to apply. No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify. Mapp is an Equal Opportunity/Affirmative Action/Disability/Vets Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law. For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/j/1053955-307440

Due to our continued growth, EMR is currently looking for Line Workers for one of locations in Camden. This is an entry level position that  requires working outside in all weather conditions. Plenty of room for advancement with great benefits! Qualifications Capable of using shovels rakes and brooms. Can stand up for 8 hours without fatigue. Understand instructions in English or Spanish. Able to recognize non ferrous metals preferred  MUST BE ABLE TO PASS A BACKGROUND CHECK AND DRUG TEST.

Please use Google Chrome or Mozilla Firefox when accessing Candidate Home. By joining the American Red Cross you will touch millions of lives every year and experience the greatness of the human spirit at its best. Are you ready to be part of the world's largest humanitarian network? Job Description: We are currently seeking an Aquatics Examiner in Milwaukee, WI. There is some flexibility on the location of our Aquatics Examiners as long as they are close to a major airport. This is a part-time, on-call position working a variable schedule to include weekdays, evenings and weekends. This position requires at least 3.5 consecutive days of availability each week from May 1st through August 31st. This position will involve travel for multiple days regionally and may also involve nationwide travel. Aquatic Examiners are a key part of the American Red Cross Aquatic Examiner Service. They are front-line individuals who visit aquatic facilities across the country and provide direct services to these sites. Their feedback and reports assist management of aquatic facilities in developing procedures that recognize aquatic hazards and outline effective responses to aquatic emergencies. Responsibilities Recording video of on-duty lifeguards both in an undercover capacity and while lifeguards demonstrate skills. Reviewing aquatic facility documentation related to lifeguard operations. Evaluating lifeguard performance in surveillance and emergency response skills on the job through on-site lifeguarding evaluations. Preparing reports and completing evaluation forms, as required. Identifying areas where aquatic facilities could improve lifeguarding operations and performance based on the American Red Cross Lifeguarding program. Conducting in-service training sessions and/or aquatic emergency action plan drills. Assisting the Aquatics Program Specialist in coordinating and conducting the annual lifeguarding operations assessment and report as needed. Mentoring new Aquatic Examiners in training. Qualifications Associate’s degree required or relevant experience. Prefer BS Degree. Minimum 3 years’ experience as a lifeguard. Minimum 2 years’ experience in a lifeguard supervisory role. Current certifications: American Red Cross Lifeguarding Instructor, American Red Cross Lifeguarding/First Aid/CPR/AED, American Red Cross Lifeguard Management. Three years’ experience teaching American Red Cross, or equivalent, Lifeguarding courses: at least one within the past year. If Aquatic Examiners will evaluate lifeguards at a waterfront or water park, they must have the basic-level certification in the appropriate course. Knowledgeable about the American Red Cross Lifeguarding Program and Aquatic Examiner Service, local and state regulations regarding lifeguard operations. Have excellent organizational, interpersonal, verbal and written communication skills. Ability to operate video equipment. Ability to effectively demonstrate, evaluate and remediate Lifeguarding skills to the American Red Cross standard. Hold a valid driver’s license and reliable transportation. Ability to travel regionally and nationally up to 100% of the time. Preferred Qualifications American Red Cross Administering Emergency Oxygen, American Red Cross Lifeguard Management American Red Cross Lifeguard Instructor Trainer American Red Cross Water Safety Instructor Trainer Physical Requirements Ability to travel 75%+. Able to work long days. Adaptable to teaching in multiple, variable environments. Physical-ability to lift up to 50 pounds, get in and out of pools multiple times during the course of a training, carry equipment variable distances to get it in and out of pool facility. **When submitting applications, please upload certifications along with your resume. Apply now! Joining our team will provide you with the opportunity to make a difference every day. The American Red Cross is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. ​ The American Red Cross is a diverse nonprofit organization offering its employee’s professional development and growth opportunities, a competitive salary, comprehensive benefits, and a collaborative team spirit environment. To be considered for this position, please visit www.redcross.org/jobs to apply. To view the EEOC Summary of Rights, click here: Summary of Rights