Document Control Specialist Jobs

Job Title: Document Control Specialist-BS in Science w/ Knowledge of cGMP! Company: Location: Oakland, CA Description: Kelly Scientific has an immediate opening with a non-profit organization in the medical transplant industry. They are looking for an enthusiastic recent graduate to fill the role of Document Control Specialist. The position is based in Oakland, CA. The Company is a non-profit network of eye and tissue banks which provides corneas and other eye tissue for sight-restoring transplant surgery. The Company also recovers tissues such as bone, ligaments and tendons (musculosketal tissue) that restore mobility, as well as skin used in burn and reconstructive surgery, heart valves to correct cardiac conditions, and saphenous veins to remedy circulatory problems. The hired candidate will play a critical role in coordinating donor information to ensure timely completion and release of ocular donor records and related information in compliance with company SOPs and regulatory requirements. Representative Duties: *Responsible for document control including: - network and local standard operating procedures - donor records management - laboratory and equipment records - event and CAPA records * Host regulatory agency and vendor audits. Manage development and implementation of subsequent corrective actions. * Oversee development, implementation and documentation of staff training curricula. * Manage accreditations and licensures for FDA, EBAA, AATB and the State of California. * Assist in writing, organizing, and maintaining technical sections of departmental procedure manuals. * Perform quality control audits as defined by standard operating procedures. Provide feedback to Executive Director as necessary to define and correct deficiencies identified. * Manage event investigations and CAPAs * Serve as the Safety Officer Requirements: 1. Bachelors Degree in a life science or equivalent education/work experience preferably in a structured regulated environment. Knowledge of cGMP and ISO 9001 a plus 2. Excellent written and oral communication skills; computer literate 3. EBAA or AATB Technical Certification a plus. 4. Excellent attention to detail and ability to coordinate multiple activities simultaneously. This is a 3-5 month Temp to Hire opportunity. (M ' F/ 8 am to 5 pm) To be considered for this position, click the 'Apply Now' button to submit your resume. All submitted resumes will be added to our national database! Or, refer a friend and click 'E-mail this Job. There is never an application fee. Kelly Scientific is the world's first and largest scientific staffing company. We employ over 700 clinical research professional and 4,500 scientist on an average workday, on a temporary, project, and full time basis, in a broad spectrum of industries and disciplines. Let us help you find your new career. Kelly Scientific is an Equal Opportunity Employer.

Job Title: Regulatory Affairs Document Control Specialist Company: Location: Raleigh, NC Description: Title: Document Control Specialist: Transform the Future of Regenerative Therapy Location: Research Triangle Park, NC Opportunity Statement: The Document Control Specialist will be responsible for organizing and maintaining company documentation to assure it is accurate, up-to-date and readily available to appropriate personnel. The individual will handle filing of all product and operations-related documents and control the revisions and distribution of these documents. • Organizes and maintains all company documents, including: written procedures, analytical methods, laboratory reports, manufacturing records, and including key financial records • Develops, follows, and updates procedures for filing, controlling, and maintaining completed written and electronic records to ensure corporate compliance with applicable regulatory requirements (both FDA and to ensure financial compliance) • Receives and organizes component documents from various sources for organization into larger, comprehensive regulatory submissions to support company clinical trial goals. • Creates and maintains tracking systems for the completed regulatory submissions and the component document versions that comprise them. • Ensures that logistics and needs for preparing and assembling regulatory filings are communicated to staff and are completed in a timely manner. • Responsible for conducting quality assurance reviews of all documents to be included in submissions prior to filing. • Works with a high degree of independence with limited supervision. QUALIFICATIONS: • 2-5 years demonstrated experience preparing FDA document/submissions and thorough knowledge of FDA regulations and submission filing requirements for INDs, annual reports, etc. • Bachelor’s degree, preferably in a health sciences field. • Advanced proficiency with electronic file management, word processing and spreadsheet/publication software to accurately generate regulatory documents (i.e. Microsoft Word, Excel, etc.) • Ability to perform and organize databases and searches for scientific literature. • Demonstrated work experience that requires strong attention to detail and ability to work well with others in a team manner to complete projects. • Ability to communicate clearly, both orally and in writing, in English, and write in a clear and understandable scientific manner. • Ability to lift and carry up to 20 pounds. As a professional search firm, we will only be responding to inquiries that most closely align with the requirements specified above. Please include position ID ( Regulatory Affairs Document Controls Specialist: CC 1223 ) in the subject line of your correspondence and forward your credentials in confidence as an attached Word document to Register to View . General CV/resume submissions for inclusion in our knowledgebase of future opportunities can be made to: Register to View For our most recent searches, please review our website at: www.ccesearch.com

Job Title: Document Control Specialist - Aerospace Company: Space Exploration Technologies Location: Hawthorne, CA Description: Company: SpaceX is an exciting, rapidly growing and entrepreneurially driven company that is changing the access to space. We are located in Hawthorne, CA, next to LAX. We are an EEO employer that offers competitive pay, comprehensive benefits and stock options. Please learn more about the company by visiting our website at www.spacex.com Job Description Our rapid growth has created an opportunity for an additional Document Control Specialist, to support the development and production of our Falcon 1 and Falcon 9 launch vehicles and our Dragon spacecraft. The selected candidate will perform the following duties Assemble, verify and scan the completed records and organize and store electronically Update the serialization Matrix and will create hanging files for hardcopy data and Vehicle Build books Organize manufacturing, production and build records for customer review Use basic Computer skills and working knowledge of Excel and Word, able to retrieve and store documents in our computer network. Requirements 5 years minimum experience in a Aerospace or Manufacturing environment, performing the function of document control including quality records Should have a basic understanding of configuration management Knowledgeable of aerospace manufacturing documents, examples: records, drawings, procedures, material and process specifications, work orders, test data and Acceptance, Qualification and As-Run procedures Ability to work with minimum supervision Excellent written and verbal communication skills to interact effectively with all levels within the company U.S. Citizenship or Permanent Residency required

Job Title: Document Control Specialist Company: Location: Philadelphia, PA Description: Pharmaceutical Document Control Specialist Document Control Specialist needed for a leading organization in Clinical Pharmaceutical Packaging. This position requires an individual with attention to detail and extensive Microsoft Word and Excel knowledge. Duties include compiling and assembling corporate metrics and client metrics. Maintenance of electronic document control system, document control records room, revise SOPs and add training requirements to SOPs. Participate in cGMP training of new employees. Competitive salary offered. Please fax resume to Amy Courtney at Register to View or email to Register to View acculogix-usa.com Source: Philadelphia Inquirer and Daily News

Job Title: QA Specialist: Document Control Company: The Henry M. Jackson Foundation Location: Rockville, MD Description: The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is seeking a Quality Assurance - Document Control Specialist to support the HIV Research Program at the U.S. Military HIV Research Program (USMHRP) in Rockville, MD. Incumbent is responsible for all aspects of document management, medical device alert management, and supporting Quality Assurance Manager in development of verification of performance and validation of new instrumentation and methodologies. Incumbent assures compliance to internal specifications and/or standards in a CAP/CLIA and FDA accredited Clinical Diagnostic Laboratory in Department of Laboratory Diagnostics and Monitoring, US Military HIV Research Program. Incumbent may conduct training as necessary; Incumbent should be able to work under minimal Supervision. QA Specialist reviews, edits, writes, and version controls all documents (SOPs, Policies, Plans, Worksheets, etc) as they pertain to HDL activities. Prepares reports, verification of performance and validation plans. Identifies CAP/CLIA/FDA regulatory deficiencies and suggests corrective actions. Works with QA Manger to upgrade and maintain Laboratory Website. Manages 6-part Training Folder, and all certification documentation. Oversees Manufacture Kit Inserts, Bulletin Updates, and Vendor/Manufacturer notifications. Oversees Medical Device Alert Program. Completes other projects as assigned. Required Knowledge, Skills, and Abilities: Knowledge of document control, validation/calibration/verification of methodologies and equipment. Familiar withwebsite maintenance. Excellent organization, computer and communication skills; ability to handle multiple priorities. Please apply on-line at www.hjf.org/careers Please click on Advanced Search and enter the Job No. 203544 in the Job Opening ID box or fax your resume to Register to View . Please specify title and job number on fax. The Foundation is a nonprofit medical research organization that provides support services to the military medical community and offers a competitive salary and generous benefits package. AA/EEO

Job Title: Document Control Specialist Company: PNY Technologies Location: Parsippany, NJ Description: US-NJ-Parsippany – Document Control Specialist PNY Technologies, Inc. is a leading manufacturer and supplier of computer graphics cards, memory upgrade modules, flash memory and flash peripherals. Its memory products currently account for a majority share of all retail sales in the US. PNY products are available at major retail outlets, mail order outlets, online retailers, value-added resellers and distribution channels throughout the US and Europe. Headquartered in Parsippany, New Jersey, PNY maintains operations in North America, Europe and Asia. For more information on PNY, please visit our website at www.pny.com . Currently, we have an opening for a Document Control Specialist in our Parsippany, NJ facility. The responsibilities for this position include: Process PNY’s design documentation; receiving design documentation from design engineers or creating it under their guidance, insuring its completeness and maintaining, filing and processing of this documentation Data entry for document control number system and Engineering Document database through the usage of Manfact, and the Engineering database Acquire required signatures for design documentation during design reviews Service documentation requirements of PNY-U.S. & PNY-EU supplying documentation upon request by: gathering documentation from Master Files, sending data package to requesting party via Fedex or similar carrier, send e-mail message informing requesting party of status. Other duties as requested Requirements: 6 – 12 months related experience required High School diploma with technical schooling or equivalent required Excellent written and verbal communication skills Highly organized Strong clerical skills MS Office knowledge Interested applicants should send resumes, with salary history. Local Candidates Only PNY is an equal opportunity employer.

Job Title: Document Control Specialist-BS in a Life Science required! Company: Location: Berkeley, CA Description: Here is a great opportunity to expand your knowledge of how your role as a Document Control Specialist fits into today's business world! This position provides an excellent opportunity to gain valuable experience in lab procedures at one of the county's leading research and pharmaceutical companies. Kelly Scientific Resources is seeking a candidate eager to successfully perform supporting ongoing laboratory development using established protocols and procedures in compliance with the company's quality system. Our client is an industry leading company based in Berkeley, California. The company has demonstrated its position as a leader in research and also in providing competent and unyielding solutions to the scientific field for over 50 years. Kelly Services full-time employees enjoy weekly pay and an outstanding benefits package that includes: ' Health (medical, dental and prescription) insurance ' 401 (k), direct deposit ' Vacation and holiday package ' Numerous employee discounts Job Description: Document Control Specialist *BS in a Life Science * 7 years experience in Records Management *1 year experience as a Document Control Specialist. *Experience with MS Office and its components, i.e Visio and Publisher. *Experience in GMP and ISO 9000 environment as a document specialist. *Experience in PC use and familiar with documentation systems. Expect more from your career. Click the Apply Now button to submit your resume and take the first step towards being a part of our winning team! Or, refer a friend by clicking the 'Email this Job' link provided. All submitted resumes will be added to our national database! Kelly Scientific is the world's first and largest scientific staffing company. Kelly Scientific Resources has grown into a $ 200 million global business as the scientific business unit of Kelly Services. Our staff of scientists provides scientific staffing to a broad spectrum of industries including: chemical, cosmetics, food science, pharmaceutical, biomedical, consumer products, environmental, medical device, and clinical, petrochemical and clinical research. Kelly Services is an Equal Opportunity Employer

Job Title: DOCUMENT CONTROL SPECIALIST Company: Location: Oriskany, NY Description: SUMMARY OF POSITION: The position involves preparing and processing of new and changed controlled documents. All shall be typed, distributed, and retrieved in a controlled manner. The coordination of artwork generated from Corporate is maintained in a controlled manner where distributed artworks are reconciled internally & externally. The position works closely with Quality Assurance as a documentation “control point” & Packaging Engineering as new artwork is generated by new product development. ESSENTIAL FUNCTIONS: 1. Type all Quality Assurance documents and serve as the Control Point for that department. 2. Distribute & retrieve revised documents to Quality Assurance. Will on occasion perform the same for Production area. 3. Maintain Drug Stability folder to be used for annual quality reviews. Maintain an audit file of all drug ingredients, values not tested here in-house, which must be audited once a year for Devices or twice a year for Drugs. 4. Manage the plant artwork system. Maintain a direct interface with Corporate and our Suppliers with regard to artwork control. 5. Participate in the conversion of Plant documents to the Corporate standard data base (Documentum). 6. Work with engineers/technicians within the department in developing new product components and related packaging artworks. 7. Will be required to participate in plant improvement projects related to documentation utilizing Lean techniques. 8. Will be required to participate in the Plant inventory exercise performed semi-annually. 9. Other duties assigned with or without accommodation. Requirements: Education required/ preferred: High School Required. Associate Degree / Bachelor preferred. Experience: Experience in an office environment as a minimum / two years preferred, experience in a medical device environment and/or within a structured documentation control system is a plus. Preferred Skills/Qualifications: Well familiar with Microsoft applications (Word, Excel, Access, PowerPoint, etc.) and other applications. Must be competent in converting files from different formats in Microsoft applications. Skills/Competencies: Thorough knowledge of Microsoft software applications that apply to data collection & word processing. Other Skills: Technical writing capability. Attention to detail. To apply online, please use the following link: Apply To Covidien

Job Title: QA Specialist: Document Control Company: Henry M. Jackson Foundation Location: Rockville, MD Description: The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is s eeking a Quality Assurance - Document Control Specialist to support the HIV Research Program at the U.S. Military HIV Research Program (USMHRP) in Rockville, MD. Incumbent is responsible for all aspects of document management, medical device alert management, and supporting Quality Assurance Manager in development of verification of performance and validation of new instrumentation and methodologies. Incumbent assures compliance to internal specifications and/or standards in a CAP/CLIA and FDA accredited Clinical Diagnostic Laboratory in Department of Laboratory Diagnostics and Monitoring, USMilitary HIV Research Program. Incumbent may conduct training as necessary. Incumbent should be able to work under minimal Supervision. QA Specialist reviews, edits, writes, and version controls all documents (SOPs, Policies, Plans, Worksheets, etc) as they pertain to HDL activities. Prepares reports, verification of performance and validation plans. Identifies CAP/CLIA/FDA regulatory deficiencies and suggests corrective actions. Works with QA Manger to upgrade and maintain Laboratory Website. Manages 6-part Training Folder, and all certification documentation. Oversees Manufacture Kit Inserts, Bulletin Updates, and Vendor/Manufacturer notifications. Oversees Medical Device Alert Program. Completes other projects as assigned. Required Knowledge, Skills, and Abilities: Knowledge of document control, validation/calibration/verification of methodologies and equipment. Familiar with website maintenance. Excellent organization, computer and communication skills; ability to handle multiple priorities. Minimum Education/Training Requirements: Bachelor's degree in Science, e.g., Laboratory Scientist, Medical Technologist, Medical Laboratory Technician, Quality Assurance Specialist. Minimum Experience: 2 to 4 years experience in Quality Assurance. Supervisory Responsibilities/Controls: The incumbent will be under the supervision of the HIV Diagnostics and Reference Laboratory Quality Assurance Manager, and Laboratory Director located as the Rockville, MD Laboratories. Work Environment: office and laboratory environment. HJF, Rockville, MD Laboratories. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Director of Human Resources. Please apply on-line at www.hjf.org/careers Please click on Advanced Search and enter the Job No. 203544 in the Job Opening ID box or fax your resume to Register to View . Please specify title and job number on fax. The Foundation is a nonprofit medical research organization that provides support services to the military medical community and offers a competitive salary and generous benefits package. AA/EEO

Job Title: QA Document Control Company: Location: Lexington, MA Description: We are currently looking for a QA Auditor to join the QA team. Description: Responsible for QA auditing of GLP related documentation Assist in the development of new processes while supporting daily site operations. Audit Bioanalytical, Dose Formulation and PK studies Review of Bioanalytical Laboratory Methods and general SOPs Perform Bioanalytical experimental lab study audits as required Requirements: Bachelor's or Master’s degree in a scientific discipline or equivalent. 3-5 years pharmaceutical industry with general Quality Assurance background, GLP auditing Required Skills: Audit, Quality Assurance, Document Control, SOP Join Aerotek Scientific LLC SM , one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.