Document Control Specialist Jobs

Job Title: Contract Quality Document Specialist Lead for Local Biotech Company: Location: Worcester, MA Description: Our local biotech client is looking for a Document Specialist Lead to join their Quality Assurance Group for a 3+ month contract. They are looking to review resumes in the next couple of days and then set up interviews from there. Duties: Processes and controls the documentation for facilities, processes, and systems as required by the current Good Manufacturing Practices (cGMP) regulations. Responsible for working with originators of GMP controlled documentation to coordinate and ensure that documents are written, reviewed, and approved in a timely manner and according to document approval schedules and deadlines. Issues document change requests and status reports; accurately follows detailed processes to edit and master SOPs. Ensures cGMP documentation is correct, clear, and consistent. Provides guidance to users of the Documentation system as well as to other Document Specialists, as needed. Updates and maintains Documentation databases. May perform data entry for tracking documents. Skills: Advanced use of MS Word; experience with MS Access and with Livelink. Education: High School diploma and 5+ years of related experience or Bachelors degree with 2+ years of related experience. Schedule: 8:00am-5:00pm Please forward your resume to Meredith Bowman Register to View and Kathleen McTeague Register to View for immediate consideration. Thank you!

Job Title: QA Document Control Specialist Company: NewLink Genetics Location: Ames, IA Description: Description: In charge of the Document Control System, processes the drafting or revision, review, approval, training, and making effective of standard operating procedures, batch production records, specifications and other controlled documents according to written procedures Reviews and edits controlled documents for correct formatting according to written procedures Distributes and collects controlled documents Performs copying, scanning and filing of documents Maintains and updates the document control and tracking databases Helps maintain and update other quality assurance databases as requested Performs other quality assurance duties as required Requirements: Proficient with advanced Microsoft Office Word, and Excel computer skills Experience with electronic document management systems is a plus Strong organizational skills Strong attention to detail with excellent written and oral communication skills Self-motivated and able to function effectively within team Education and Experience: Bachelor's degree (B.S.) or related experience and/or training strongly preferred How To Apply: Mail, fax or email resume and cover letter to: Attn: Human Resources NewLink Genetics 2901 South Loop Drive Bldg. 3, Suite 3900 Ames, Iowa 50010 Fax: Register to View Equal Opportunity Employer.   See all jobs in Ames IA

Job Title: Pharmaceutical Quality Assurance/Document Control Specialist Company: Applied Laboratories, Inc. Location: Columbus, IN Description: Pharmaceutical Quality Assurance/Document Control Specialist Seeking a detail-oriented individual with a positive attitude to fulfill the role of Quality Assurance/Document Control Specialist. Responsibilities for this position include but are not limited to: * Write and review SOP's, batch records, and other control documents * Write and approve change requests and document variances * Conduct internal Quality System audits, assist with annual product reviews * Maintain SOP, batch and packaging records, form book, and method book index * Release finished product in Data Management System * Prior experience required in Pharmaceutical Document Control * Proficient in MS Word and Excel Applied Laboratories, Inc. Submit resume on-line to Register to View Or Fax: Register to View

Job Title: QA Document Specialist Company: Verdure Sciences Location: Noblesville, IN Description: Description:Job Purpose:Maintains quality compliance by identifying quality requirements; disseminating standards, policies, and procedures; conducting audits; recommending improvement plans. Maintaining records.Duties:* Identifies quality requirements by reviewing regulations, guidelines, and standards, including International Committee on Harmonisation (ICH), International Organization on Standardization (ISO), Good Manufacturing Practices (GMP), and Environmental Protection Agency (EPA).* Communicates quality goals and requirements by preparing and disseminating standards, metrics, standard operating procedure (SOP) management, and contractor document and production records guidelines.* Assesses quality compliance by conducting audits; analyzing and verifying documentation; reviewing process changes.* Improves quality compliance by recommending and following-up on improvement plans; writing procedure updates.* Prepares quality assurance reports by collecting, analyzing, and summarizing data and trends.* Protects organization's competitiveness by keeping information confidential.* Updates job knowledge by reviewing changes in good manufacturing practices (GMP), good laboratory practices (GLP), and regulatory requirements; participating in educational opportunities.* Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.Skills/Qualifications:Quality Management,  Documentation Skills, Reporting Skills, Analyzing Information, Problem Solving, Process Improvement, Verbal Communication,  Attention to Detail.

Job Title: Quality Document Specialist Company: Kelly Services Location: Neenah, WI Description: Quality Document Specialist Kelly Services in partnership with Plexus is currently hiring for a temporary Quality Document Specialist in the Neenah area.  Job Responsibilities include:* Communicates with suppliers regarding quality requirements.* Drives supplier quality improvement.* Resolves supplier quality product issues.* Issues and tracks quality documents. Generates and reviews reports to assure that suppliers respond to corrective action requests.* Drive cost recovery efforts back to the supplier to recover labor and part costs due to supplier defects.* Minimal travel may be required to meet the needs of the business.* Additional duties as assigned by management.Education/Experience required:* A minimum of an Associate's Degree or equivalent experience is required, an Associate's Degree is preferred.* Experience of less than 1 year(s) is required for this position assuming education requirements are met, equivalent industry experience of 1 or more year(s) is highly desirable.* Previous Electronic Assembly experience is helpfulSkills/Knowledge/Abilities:* Intermediate Computer Skills* Intermediate decision making, problem solving skills* Intermediate verbal and written communication skills1st shift hours, Monday - Friday 8am-4:30pm**previous applicants need not apply** Kelly Services is an Equal Opportunity Employer.

Job Title: Regulatory Document Control Specialist Company: Kelly Scientific Resources Location: Corvallis, OR Description: Kelly Scientific Resources has an immediate opening for a Regulatory Document Control Specialist at a Pharmaceutical company in Corvallis, OR. This individual will be responsible for managing the filing of regulatory documents.Responsibilities could include:Provide quality control, management, maintenance and processing of regulatory documents to ensure compliance with Federal Regulations and Standard Operating Procedures. Responsible for the maintenance of all required documentation for the company. Provide services to maintain and control Master Record documents. Responsible for word processing and distribution of documents and maintenance of document files in a confidential and secure manner. Provide comprehensive administrative services to coordinate and maintain Good Manufacturing Practices (GMP), cGMP control changes to currently manufactured products and associated with the current manufacturing system. Manage release and control of updates to instructions, specifications, and other documents. Control distribution of new releases and recall/destruction of obsolete documents. ?Requirements: Must have a Bachelors degree or equivalent training and experience in a clinical research environment. Prior experience utilizing Documentum or similar document or content management system, proficient in Microsoft including editing, formatting, utilizing templates, creating forms and embedding hyperlinks. Prefer 1-3 years of document management experience in a laboratory, quality assurance/quality control, IRB or clinical research department. Kelly Scientific is a division of Kelly Services - an international, Fortune 500 Company with a reputation for excellence. Kelly Scientific is devoted to partnering with companies to provide scientific professionals with the best possible positions to meet their career goals. For more information, visit www.kellyscientific.com

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: QA Document Control Admin Company: Volt Workforce Solutions Location: Irvine, CA Description: Volt has partnered with a leading company in Rancho Santa Margarita to help identify an experienced QA Document Control Admin for an immediate 3 - 5 month temporary opportunity. Our client is a mid size company that performs pharmaceutical manufacturing. In this role, you will be responsible for; performing word processing of documents, drafts and revisions submitted for proofreading; maintaining accurate and secured electronic and hard copy files of QA documents; assigning document numbers to procedures; assigning approval routing; maintaining the executive filing system; and ensuring GMP/ISO compliance and continuous improvement in all document control activities. Position pays between $15 - 16/hr. Submit resume today for immediate consideration. Volt Workforce Solutions is an Equal Opportunity Employer with a commitment to fostering diversity in the workplace. For more job opportunities with Volt please visit our web site at http://jobs.volt.com .Requirements: Qualified candidates will possess a minimum of 2 - 3 years experience in document control, preferably within the medical manufacturing industry. Training in GMP/ISO is highly preferred. Must possess excellent verbal and written communication skills and be proficient in MS Office.

Job Title: Document Control Specialist Company: Digital Technology Solutions Location: Somerville, NJ Description: Document Control Specialist with Records Management experience Document Control Specialist Location: Somerville / NJ Duration: 1 year Description: Manages release and control of updates to instructions, drawings and other documents. Controls distribution of new releases and recall-destruction of obsolete documents. Support the records management project objectives. Prepare periodic status reports. Accurately sort, file, mail and copy critical-vital records. Accurately input data in a database spreadsheet and provide reports as requested. . Provide 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. Collecting supporting design control documentation; working with assigned team(s) to do so. Submitting documentation for approvals and insuring timely responses Drafting documents under product engineer oversight Migrate documentation into Client document management and design history file systems Transfer control of project team documentation to Corporate Document Services upon product release. Support project teams during internal & external agency audits as required Asist Sponsor Teams and Project Leadership Teams during technical design & gate reviews Skills Requirements: 3+ years experience as a documentation specialist supporting pharmaceutical or medical device product development activities Experience in quality systems compliance a plus. Working knowledge of ISO (International Organization for Standardization) and FDA (Food & Drug Administration) records management requirements preferred Strong organizational and time management skills; able to take complex, ambiguous situations & organize into sensible & well planned functions Detail-oriented Personal computer software - Windows, word processing, presentation, e-mail, flow charts, calendar & spreadsheet software Please forward your profiles to Register to View -it.com

Job Title: Temporary Document Control Specialist Company: Location: Los Angeles, CA Description: Spectrum Labs, a high-tech leading supplier of biofiltration devices, is seeking a Temporary Document Control Specialist to join our growing team. Responsibility and authority: ? Manages engineering and quality document control system. ? Maintains fully-automated system to electronically store, retrieve, update, and distribute engineering and manufacturing documentation. ? Assists in the development of all types of company documentation. ? Assists in Scheduling and managing ISO, quality, and documentation meetings. ? Ensures timely and accurate revisions to and distributions of pending and approved company documentation relating to policies, procedures, processes and products. ? Ensures accurate retention of company documentation relating to policies, procedures, processes and products. ? Participates in project planning with the development teams and supports team efforts as needed. ? Conducts/participates in internal audits. ? Supports facility audits conducted by customers and regulatory agencies. ? Generates/manages Document Change Orders (DCO). ? Procures signatures on DCOs. ? Enters bills of materials and modifies BOM?s as required by MIS. ? Assists Engineering with AutoCAD changes. __________________________ Minimum qualifications and experience requirements: ? Minimum AA degree or equivalent experience. ? 2+ years of experience in Document Control. ? Familiar with ISO 9001, computer literate, knowledge of engineering and medical devices. __________________________ Delegation of Duties during absence (indicate position title): ? To be determined by the Director of Quality Assurance and Regulatory Affairs Duration of the job - June 2010 to November 2010