Document Control Specialist Jobs

Job Title: Document Control Specialist/Administrator Company: Medical Concepts Development Location: Woodbury, MN Description: Medical manufacturing company has an immediate opening for a Document Control Specialist administrative position.This position provides support for the overall document control system.Primary area of responsibility is to maintain the document system process and support document change requests affecting all company wide documents.  Primary interface will be with engineering, quality and manufacturing personnel.Assure compliance with company procedures, medical regulations and external standards established by regulatory agencies.Three to five years experience in a regulated industry and familiar with FDA, MDD and ISO quality management system document control requirements is preferred.In addition, computer skills, excellent administrative organizational and communcation skills are necessary for success in this position.

Job Title: Document Control Specialist (Proficient in MasterControl Software) Company: ImpediMed Limited Location: San Diego, CA Description:  DOCUMENT CONTROL SPECIALIST Proficient in MasterControl Software  ImpediMed, www.impedimed.com, a global medical device leader headquartered in San Diego is seeking a detail-oriented Document Control Specialist to join our growing team. POSITION SUMMARYUnder general supervision, the Document Control Specialist is responsible for administering the company’s controlled documents in accordance with customer, company, and regulatory requirements ( ISO 13485, TGA, and FDA CFR Title 21 Part 820). ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  Other duties may be assigned. Facilitate the Change Control and Document Control Procedures utilizing the company’s document control system, MasterControl, in accordance with our Quality Management System.  Ensure all documents are complete, accurate, and current prior to release.  Assist in the development, deployment and maintenance of templates for documents, manuals and forms.  Assist in creating schedules for ISO, TGA, FDA, or other regulatory audits and support audits. Provide training to ImpediMed staff on document release and change control process. Responsible for effectively communicating Document Release and Quality department information to all levels in the organization, through training, newsletters, emails, or other methods. Be responsible for retrieval of all outdated documents prior to release of all controlled documents. Quality System Regulations (QSRs) both US and international. Log, track, route, and report on the status of Corrective and Preventative Actions (CAPA’s), Non Conformities, (NC’s), and customer complaints. Establish procedures for Document Control and implement procedures (Standard Operating Procedures, Work Instructions, …) through our Quality Management System.   OTHER RESPONSIBILITIES Be the resident expert in the use and expansion of MasterControl and be the “go to person” for help using the system.  Take the lead position and be responsible for transitioning archived documents from previous systems into MasterControl. Work with IT Department to establish retention and recovery criteria for electronic records. Manage storage of paper records at on or off-site locations. Interface and assist other departments in the development of specific documentation. Establish applicable metrics for the change and control process of documents and develop improvements based on those metrics. Resolve and/or escalate critical issues proactively.  Additional duties to be assigned as needed.   SUPERVISORY RESPONSIBILITIESNone. QUALIFICATIONS REQUIREDTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Knowledge, skills, & abilities: Must be proficient with MasterControl for document control. Must understand, follow, and comply with regulatory requirements as applicable to various processes. An understanding of FDA Quality System Regulations and ISO Standards (ISO 13485) is a plus.A thorough understanding of work related standards and regulations that apply to your job responsibility, including but not limited to; Standard Operating Procedures (SOPs), Work Instructions, Quality System Regulations (QSRs) both US and international. Ability to focus on meeting and exceeding internal customer requirements. Excellent communication skills are required, including the ability to actively listen and effectively present information to other employees of the organization. Position requires a self starter with a strong attention to detail and the ability to prioritize work and meet deadlines. Must have excellent follow-through and organizational skills.  Proficient in Microsoft Office programs including Windows, Word, Excel and Outlook.Ability to work on challenges of moderate scope, using judgment and initiative to resolve problems and make recommendations. Ability to complete routine tasks and new assignments with general instruction. Must be able to work collaboratively with all levels of employees.  MINIMUM EDUCATION and/or EXPERIENCEProficient working knowledge of MasterControl software for document control is a must. Minimum of three years related experience in Document Control in a medical device, pharmaceutical, or related field. High school diploma or general education degree (GED). College preferred but not required. Knowledge of the medical device industry, FDA Quality System Regulations, and/or ISO Standards is a plus.  REASONING ABILITYAbility to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations.PHYSICAL REQUIREMENTSMust be able to lift weight of up to twenty (20) pounds of force on an occasional basis, and a negligible amount of force to lift, carry, push, pull, or otherwise move objects. Ability to use a computer for extended periods of time to enter and process customer information.  BENEFITSInclude health insurance, 401k, stock incentive plan. Submit Resume and Cover Letter To: Register to View ImpediMed, Inc. 5959 Cornerstone Court WestSuite 100San Diego, CA 92121An Equal Opportunity Employer

Job Title: Document Control Specialist Company: Volt Workforce Solutions Location: Centennial, CO Description: Job Description:The Document Control Specialist is responsible for creating and updating Engineering documentation. Duties include general drafting for a variety of product related requirements. This position also includes Change Order processing.Responsibilities include producing all types of documentation for the production, assembly, and customer use, maintenance, and trouble-shooting of electrosurgical equipment, with the support of the Engineering, Regulatory Affairs, and Quality Assurance staff, and assistance to suppliers and other departments as needed. This position requires frequent decisions to be made pertaining to documentation, product labeling, and Operator and Service manuals. These decisions must be made correctly and usually quickly in compliance with FDA GMP and international regulations, corporate SOPs and policies, industry standards, and customer and vendor requirements. These decisions may affect project schedules, product availability, and regulatory compliance.This position requires frequent decisions to be made pertaining to documentation, product labeling, and Operator and Service manuals. These decisions must be made correctly and usually quickly in compliance with FDA GMP and international regulations, corporate SOPs and policies, industry standards, and customer and vendor requirements. These decisions may affect project schedules, product availability, and regulatory compliance.Job Requirements:QUALIFICATIONS:High school or equivalent.Competent in the use of standard drafting equipment, plotters, printers, xerographic copiers, technical publishing lay-up programs, Acrobat Professional; Photoshop, digital cameras, and desktop computers.Excellent attention to detail and documentation skills; and the ability to work on multiple overlapping projects.

Job Title: Document Control Specialist - Company: Location: San Francisco, CA Description: Seeking a document Control specialist for fast paced manufacturing company. Self motivated, quality minded and have a good understanding of process flow. Must work well under pressure. Must have a minimum of 3 years experience document control &/or in Contract Manufacturing. Responsibilities: ? Create / Update Work Instructions ? Process Internal ECO?s ? Process Customer ECO?s ? Read, understand and process customer supplied drawings & specifications ? Enter & update Daily Production Schedule ? Maintain ISO 9001:2008, AS9100 files, forms, procedures ? Maintain a clean work environment ? Release Work Orders ? Maintain document flow through order fulfillment: ? Run daily, monthly SPC data reports ? Maintain production metrics which include manufacturing volume, yield, and failure analysis Qualifications: ? High School Diploma required ? Excellent English communication skills, written and oral ? 3+ years experience in a manufacturing facility ? Proficient computer skills: Word, Excel, PowerPoint, and inventory management system experience is a plus but can be taught ? Attention to detail is a must have ? Team player committed to quality and working effectively with others ? Motivated self-starter, results oriented, flexible, dependable, organized, efficient work traits, disciplined and able to work with minimal supervision Respond to this ad

Job Title: QA Document Control Coordinator Company: Encadria Staffing Solutions Location: Jacksonville, FL Description: Encadria Staffing Solutions is looking for a QA Inspector. Position M-F 8:4:30. This position is a direct hire and pay 10-13hr based on prior work experience. Only applicants with prior QA experience will be considered. Supervise and coordinate all activities related to the document control. EQUIPMENT Tape Measures Force Gauge (Chatillon) Calipers Computer hardware/software Telephone Fax Machine RESPONSIBILITIES/DUTIES Revise and update Quality and Regulatory documents. Manage and maintain Quality and Regulatory documents in MASTERControl. Ensure all quality system documents meet Quality Manual and Corporate Procedure requirements. Maintain Device History Records (Finished Goods and Raw Material) subject to incoming inspection at Jacksonville Facility. Act as a liaison with Columbus’/DR Technical Service/Specification Provide support to all departments in MASTERControl Software System. Maintain organized filing system for the QA/RA department (CAPA, Complaints, Internal/External Audits, Management Review Meeting Minutes, Nonconforming Reports (MRB’s) and Scrap Authorization files). Maintain Quarantine/QC Hold Reports. Responsible for products under Quarantine/QC Hold status. Provide assistance during regulatory and customer audits. Perform verification tasks relating to product specifications. Perform disposition of Return Goods (RMA). Generate monthly Return Goods Report (RMA). Conduct in-process inspections among all process performed within the Pack Out department. Maintain the equipment calibration list, certificates and assure all equipments used are within calibration date. Perform calibration in house to applicable equipments and take necessary actions to equipment calibrated by third party. Other duties in which employee has training and/or skills necessary to perform tasks successfully. QUALIFICATIONS/COMPETENCIES Associate’s degree (AA) or equivalent from a two year college or technical school or six months to one year related experience and/or training or equivalent combination of education and experience in Administration and/or computer skills. Working knowledge of Microsoft Word, Excel, PowerPoint, Microsoft Visio (Flow-charter). Must posses excellent verbal and written communication skills and be able to perform under pressure to meet deadlines. Knowledge of the use of some measurement equipments. Able to work in office setting and dexterity to use keyboard. Use of fingers, hands or feels objects Stand, sit, stoop, kneel, and crouch. Close vision and depth perception Frequent lifting. Reference Physical Requirements Checklist. WORK ENVIRONMENT Regularly exposed to moving equipment. Regularly exposed to extreme cold and heat. Noise level is usually moderate. Office – controlled climate and moderate noise. We offer competitive wages and benefits. Prior to beginning all work applicants must be willing to comply with our drug screening policy and submit to a background check, inclusive of criminal. We welcome and encourage diversity in our workforce. Encadria Staffing Solutions is an Equal Opportunity Employer. If interested please submit a plain text resume in Word format today to Register to View Due to the large number of responses we receive to our job postings, only those applicants with the needed experience, applicable educational requirements and qualifications will be acknowledged.

Job Title: Document Control Specialist II Company: NetSource, Inc. Location: Somerville, NJ Description: Please note that this is a 1 year contract position. EDUCATION: Bachelors of Arts (BA) or Bachelor of Science (BS) degreeKEY SKILL / KNOWLEDGE REQUIREMENTS: SKILL SETS:Interpersonal skills to deal effectively with internal & external customers * all levels.Ability to work in a team environmentAbility to organize and manage project documentationCommunication / presentation skills * verbal and written. Technical writing skills, a plusAbility to compose documents / presentations from minimal notes.Strong organizational and time management skills; able to take complex, ambiguous situations & organize into sensible & well planned functionsDetail-oriented High degree of confidentiality / sensitivityAbility to listen and take direction, seeking clarification where necessaryOperate commonly used office equipmentAbility to work through conflicting information to find solutionsEffective problem analysis and solvingAbility to work independently, with little supervision, to ensure timely completion of tasksWorking knowledge of ISO (International Organization for Standardization) and FDA (Food & Drug Administration) records management requirements preferredCOMPUTER SKILLS:Personal computer software Windows, word processing, presentation, e-mail, flow charts, calendar & spreadsheet softwareKnowledge of Internet requiredKnowledge of Internal Intranet and business applications (such as ECCS [Internal Change Control System] and eDHF [electronic Design History File]) a plus.Takes initiative to update knowledge of new software relevant to the position.JOB EXPERIENCE:3+ years experience as a documentation specialist supporting pharmaceutical or medical device product development activities Experience in quality systems compliance a plus.KEY JOB RESPONSIBILITIES: POLICIES: Know & follow Internal policies & procedures related to work activities performed in area of responsibilityTRAINING: Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments & for implementation of new policies & procedures. Complete required periodic re-training in areas such as safety & environmentalSAFETY: Follow all company safety policies & other safety precautions within work area. Promote safety to all associates that enter work areaProvide documentation support to project teams: including:Organize and maintain project team documentation (electronic and/or hard copy) to comply with Corporate Quality System regulations through product release. Formatting documentation and inputting into Corporate Quality Control systems (ECCS, eDHF)Collecting supporting design control documentation; working with assigned team(s) to do so.Submitting documentation for approvals and insuring timely responsesDrafting documents under product engineer oversightMigrate documentation into Internal document management and design history file systemsTransfer control of project team documentation to Corporate Document Services upon product release.Support project teams during internal & external agency audits as requiredAssist Sponsor Teams and Project Leadership Teams during technical design & gate reviewsOther responsibilities may be assigned & not all responsibilities listed may be assignedFor consideration please include Dice # 5454

Job Title: Quality Assurance Document Control Specialist - Company: Location: San Diego, CA Description: POSITION TITLE: Quality Assurance Document Control Specialist REPORTING TO: Quality Manager OBJECTIVE: GenWay Biotech is working to become GMP and ISO certified. The person filling this position will play a major role in helping the Company to achieve that objective. RESPONSIBILITIES: This is a part-time, junior, but not entry-level, position involving support to the Quality Manager in completing the following tasks: ? Write new SOPs and other QA/QC documents. ? Convert existing old formatted documents into GenWay?s new format. ? Help keep Document Control system up to date. ? Execute document change requests, and generate new document versions. ? Assign new document numbers. ? Review written documents before releasing into system. ? Help maintain GenWay?s quality system. ? Maintain and create new employee training records. The position is part-time and hourly, but can lead to a salaried, full-time position. GenWay is a small company, and everyone performs certain other duties, in addition to their primary responsibilities. The attitude we look for is one of ?How can I help?? GenWay reserves the right to modify the above responsibilities as the needs of the Company change from time to time. EMPLOYEE REQUIREMENTS: The candidate should possess all or most of the following attributes: ? A minimum of an AA college degree with emphasis in Biology, Bioengineering, Biochemistry, Immunology and related subjects. ? Minimum of one year of Quality Assurance experience in a laboratory environment. ? Good writing skills. ? Attention to detail. ? Carry out assignments in a thorough, conscientious fashion. ? Proficient in MS Word and Excel ? Good communication skills, both written and oral. ? Excellent documentation and organizational Skills. ? Ability to work intelligently and independently in a small start-up environment. ? Upbeat, positive attitude and high energy level ? Good work habits ? Desire to learn and grow ? Highest ethical standards ? Commitment to excellence. Highly accurate in both bench work and in paperwork. The successful candidate must be an independent self-starter, good at problem solving, and love the challenge of achieving ambitious goals. COMPENSATION AND BENEFITS PACKAGE: Compensation is $15 per hour. The work schedule is 20 hours per week. There are no employee benefits. However, as the company grows, and the candidate demonstrates his/her abilities, there may be an opportunity to convert to a salaried full-time status, with standard company benefits. Please submit resume to Register to View