Documentation Coordinator - QA - Co-Op

pbuJob Description/u/b/pp/ppbJob Posting Title: Documentation Coordinator - QA - Co-Op/b/pp/ppspanspanb12 Month Co-Op Opportunity for an ELIGIBLE student in a Co-Op program - must maintain Co-Op eligibility until end of Co-Op work assignment./b/span/span/pp/ppbSummary: /b/ppResponsible for receiving, filing, controlling, and retrieving of executed GMP documents such as batch records and validation reports, including off-site storage. Maintains the controlled document library (archives), this includes routine filing. Manage the process for disposition of executed GMP documents, including shipment of documents to Clients or destruction of Client and Site documents. Support Compliance Auditors in audit preparations including document retrieval and assembly. Compliance projects as required./pp/ppbEssential Functions: /b/pulliAccurately maintain document database and archives./liliRetrieve documents in a time sensitive manner./liliEnforce procedures governing document management and compliance requirements including records retention policies. Must collaborate cross-functionally to reinforce site requirements./liliResponsible for the maintaining access to the controlled Document Library including the removal and return of records stored within. Includes offsite storage of documents./liliSupport onsite Customer and Regulatory audits./liliReceive, file, and retrieve documents./liliManage process for disposition of executed GMP documents that have reached their retention periods, including shipment of documents to Clients or destruction of Client and Site documents./liliPrepare documentation for offsite storage./liliSecure required documentation on time to maintain client deadlines. Work with other departments to locate documents./liliRespond to regulatory, customer or internal requests for document information and to general questions pertaining to document control./liliFacilitate periodic review (reconciliation) of controlled documents in accordance with site procedure./liliMaintain a safe working environment and report potential hazards./li/ulp/ppbREQUIRED QUALIFICATIONS/b/pp/ppbEducation: /b/ppHigh school diploma/General Educational Development (GED) Certificate is required/pp/ppbExperience: /b/ppRequires no previous experience.br / /ppbEquivalency: /b/ppEquivalent combinations of education, training, and relevant work experience may be considered./pp/ppbKnowledge, Skills and Abilities:/b/ppOrganized and detail oriented. Demonstrated computer proficiency in Microsoft Office products (Word, Excel, PowerPoint). Ability to work on multiple projects simultaneously. Exceptional communication and interpersonal skills. Proficiency with the English Language./pp/ppbStandards and Expectations: /b /ppFollow all Environmental Health Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems SOPs and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field. /pp/ppbPhysical Requirements: /b/ppModerate physical effort and fatigue. Walks, sits or stands for limited periods. May require recurring stretching or reaching. Regular movement of files, binders and boxes of documentation to and from off-site storage. Climbing of ladder to reach upper shelves. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally./p