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THIS POSITION IS FUNDED BY AMERICAN RECOVERY AND REINVESTMENT ACT (ARRA) FUNDING. The Vaccine Clinical Materials Program, SAIC-Frederick, Inc. supports the Vaccine Research Center in manufacturing materials for Phase I & Phase II clinical trials. Develop, optimize, and qualify new analytical methods for the physical and chemical characterization of biopharmaceuticals; identify, set up, operate, and maintain applicable instrumentation for routine and non-routine Quality Control testing in compliance with FDA cGMP/GLP requirements and all VCMP operational procedures. Work with Process and Technology Development groups to identify and implement methods for process impurity analysis. Duties include managing multiple projects and training less senior-level lab personnel in the Assay Development group, and assisting management with technical transfer of assays from outside collaborators and to the VCMP QC group. Follow good documentation practices in all aspects and phases of the work; independently design, execute and interpret experimental data; provide reports and SOPs for review in a timely manner; perform analytical and instrument problem solving; participate in out-of-specification and failure investigations and recommend possible corrective actions; draft and execute qualification protocols; perform equipment qualifications (IQ/OQ/PQ), maintain lab equipment and the safety and orderliness of the lab; apply knowledge of cGMPs and GLPs on a daily basis. REQUIRED SKILLS: Bachelors degree from an accredited college/university in Chemistry, Biology, or other related scientific discipline or equivalent or four (4) years of relevant experience in lieu of degree. Foreign educated candidates who have completed part or all of their education outside of the United States must have their foreign education evaluated by an SAIC-approved accrediting organization to assure that it has met the equivalency of the qualifications of degree work in the United States. In addition to the education requirement, a minimum of 4 years experience and demonstrated working knowledge of biochemical analysis of proteins, nucleic acids, and / or viruses and ones year in a supervisory role in a GMP or biopharmaceutical environment. Strong hands-on technical skills and ability to apply a broad range of analytical techniques (e.g., HPLC, GC, CE, various spectroscopy, GC/MS, LC/MS, DLS, etc.) to develop, optimize, and validate assays. Working and trouble-shooting capability with computer-operated laboratory instrumentation, highly competent written and oral communication skills in working with external and internal departmental staff, and good technical writing skills are required. May be required to work flexible hours including weekends and evenings and may work in a BL2 environment. This position is subject to obtaining a Public Trust Clearance. DESIRED SKILLS: Demonstrated knowledge and expertise in chemical analyses using numerous techniques including HPLC, MS, GC, DLS, and CE as apply to the biotechnology industry. Background in developing and trouble shooting analytical methods for physical and chemical characterization of plasmid DNA, viral, and protein API and finished products, process impurities, degradation, and excipients. MALDI-TOF and other protein-specific analytical experience a plus. Experience with method development, validation, or new method transfer. Working knowledge of DOE and statistics, cGXPs, 21 CFR Part 11 compliance, and guidelines pertaining to biopharmaceutical analysis; development experience in pharmaceutical testing labs. Strong communication and organizational capability in managing other analytical personnel.
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ORIGINAL JOB LISTING Audit Manager (Quality Control)Location: Rockville, MDSalary: 110KContact: Bob LucasPhone: Register to View Fax: Register to View Growing public accounting firm seeks CPA current on all FASB and accounting standards to do quality control functions for the firm. Individual can also get involved with outside firm peer review work. Prefer seasoned individual with 10-15 yrs. current or very recent public accounting experience.Date Posted: 03/05/10
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Quality Manager - Industrial Products Job
Quality Manager - Industrial Products-QUA100CKDescriptionThe Quality Manager - Industrial Products is responsible for the interaction and influencing of Regulatory Agencies associated with the Industrial Microbiology products and new technologies and / or interactions between the business and Customers to drive Quality Interaction, Improvement and Systems related to products and technologies. Ensures projects are completed within schedule and on budget. Accomplishes results through various level managers / supervisors. May manage budgets, resource dollars and equipment. Provides technical leadership and functions as an advisor to a plant or subunit regarding tasks, projects and operations. Is the key representative to internal sales and marketing organization, the plant leadership teams and external customer representatives at various management levels concerning various phases of projects / contracts. Interprets and executes regulatory policies and procedures affecting functional units. Recommends modifications to Operating policies, procedures and practices that can affect the operating unit.DUTIES AND Responsibilities: Maintains a full working knowledge of BD products and customer usage of same. Keeps current with all applicable regulatory agencies and said requirements that apply to products sold or in development. Interprets regulatory requirements / changes for products and communicates and facilitates necessary changes to BD systems or processes to assure compliance to appropriate regulations / changes. Engages regulatory Agencies influencing outcomes. Responsible for WW Regulatory and Compliance Monitoring and Response Works directly with customers to understand customer needs, expectations, and influence outcomes. Leads Sales and Marketing in developing an understanding of applicable regulations and influencing customer outcomes. Acts as key functional or cross functional liaison with stake holders concerning operational or project deliverables. Provides Leadership to drive business growth through compliance to Quality and Regulatory requirements. Manages Customer Expectations. Drives system changes and projects related to new Industrial Product opportunities. Works with plant Leadership to implement.QualificationsMINIMUM REQUIREMENTS:EDUCATION AND SKILLS / ABILITIESBS / BA and 9 years experience where 4-6 years include supervisory / leadership responsibilities and Regulatory experience / influencing.MS/MBA and 7 years where 5 years include supervisory / leadership responsibilities. Experience in Customer Interaction with proven outcomes and interactions with Regulatory Agencies preferred. Phd or post graduate studies preferred. Demonstrated ability to lead, motivate and accomplish results through lower level subordinate supervisors or experienced direct reports. Demonstrated talent management skills. Able to influence Regulatory Agencies and represent BD. Able to interpret Regulations and implement practical changes to Quality Systems to comply with regulations. Demonstrated experience working with regulations from and directly with USP, EP, JP Parental Drug Association, AOAC and FDA Able to work directly with customers to drive positive outcomes. Able to organize and prioritize assignments providing direction to and participation in assigned functional teams. Able to maintain strategic and tactical interaction with local leaders and unit level leaders. Demonstrates excellent written and verbal communication skills across all levels. Ability to represent functional and operations organization with clarity and manage conflict resolution in wide variety of settings. Supports and drives change management within function and / or across business unit. Able to manage customer satisfaction initiatives. Broad knowledge and understanding of the Food an Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) and WW Regulations associated with product portfolio. Ability to effectively manage financials.JobQuality ManagementPrimary LocationUS-Maryland-BaltimoreShiftFirst Shift / Day JobRelocation AvailableNo
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Director, Quality Improvement (QI)Requisition Number: 27576Department: Quality ImprovementSchedule: Full TimeShift: DayHours: 8:30 am - 5:00 pmWork Location: AdministrationContact Information:Email: Register to View Details: - Master's- 5 yearsUnder the supervision of the Senior Director for Quality Improvement, this position is responsible for directing the hospital's Performance Improvement programs to enhance quality of care provided at the Johns Hopkins Hospital. This position is responsible for the day-to-day operations, selection and ongoing development of the QI Department professional and support staff. This position utilizes leadership and operational expertise plus knowledge and application of the PDSA framework using evidence-based practice, quality literature, theories of quality / innovation, and statistical processes to facilitate the operationalization of the organization's quality and safety goals. This position provides leadership to the clinical departments to ensure the appropriate quality / safety projects and priorities are identified on an annual basis and that departmental resources are assigned appropriately to achieve performance results across the organization and at the local clinical department level. This position assists in the development and execution of organizational priorities, provides a link to the clinical departments to ensure organization-wide focus, establishes and maintains benchmarks for quality improvement, and achieves performance improvement results. This position tracks and reports progress timely on quality improvement results or outcomes, identifies gaps in current performance, and strategizes to achieve improvement with sustainability.Education: Work requires a professional level of knowledge in health and quality improvement field as acquired through a Master's Degree in Nursing, Business Administration, or Healthcare Administration. Knowledge: Excellent knowledge base of performance improvement theory and application, financial and data analysis, national, state and local quality improvement initiatives, regulations, and accreditation requirements. Experience with Microsoft Office programs and/or with word processing, databases and spreadsheets. Skills:Quality improvement tools and techniques (PDSA, Lean Thinking, Six Sigma, etc.); effective leadership and management skills; advanced interpersonal skills, ability to make presentations and interact with all levels of internal and external stakeholders; program development skills; advanced oral and written communication skills; demonstrated ability to influence through effective negotiation re: individual and group decision making; ability to develop and maintain credibility throughout the organization function effectively in a fluid, dynamic and rapidly changing environment; demonstrated ability to analyze, synthesize, and summarize information using statistical process to make sound judgments. Superior interpersonal skills necessary to exchange information, make recommendations and resolve problems attendant to quality assurance issues. Required Licensure, Certification:Preferred but not required licensure in the State of Maryland as a Registered Nurse, Medical Doctor, Physician's Assistant, or Healthcare Quality Professional with quality improvement experience. Prefer quality improvement certification. Work Experience: Requires 5-7 years of quality improvement experience and a minimum of 3 -5 years of managerial experience. Work requires a comprehensive understanding of performance improvement, quality assessment, risk management etc. Requires extensive knowledge base and experience with public reporting, pay for performance, national quality improvement initiatives and performance trends, APR DRGs, coding optimization, third-party payor requirements related to quality indicators, and JCAHO, CMS and other regulatory standards.
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Quality Management System SpecialistStinger Ghaffarian Technologies (SGT, Inc.), a government contractor with over 1,500 employees nationwide is seeking a Quality Management System Specialist for our corporate headquarters in Greenbelt, Maryland.
The QMSS will develop procedural documentation in support of quality system certifications, including CMMI and ISO 200000. Conduct internal audits to verify conformance with the procedures and the standards.
Strong written and spoken communication skills; willing to travel; excellent interpersonal skills; self-motivated; highly proficient with Microsoft Office suite and the Internet Applications; competence in IT System Management and familiarity with ISO 9001/AS9100, CMMI, ISO 20000 and other quality methodologies a plus. Candidates must be a "US Person" as defined by ITAR reguliations.
SGT offers a comprehensive benefits package; including health, dental, vision, life, long and short term disability, and 401(k) with employer contribution. SGT is an Equal Opportunity Employer EOEm/f/d/v. Interested applicants should apply on-line at www.sgt-inc.com.
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My clients have asked me to work on a handful of QC Mgr roles for Biotech companies both in MD and PA. Candidates must have a background in biologics. Very good opportunities with solid companies. Please feel free to send me your resume for consideration.
I look forward to hearing from you
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Director, Quality Management SystemsJob ID: 2136# Positions: 1Location: US-PA-Blue BellPosted Date: 2/1/2010Job Category: Operations SupportCDL Required: NoLifting Required: NoTravel Required: YesApply for this job:* Apply for this jobonline* Refer a friend to this jobMore information about this job:Overview:Company Overview:Henkels & McCoy is one of the largest privately held firms providing project management, engineering, construction, installation, maintenance and training services to utility, commercial, industrial and government customers. We have more than 80 offices strategically located from coast to coast.Position Reports to: Vice President, Information and Performance SystemsLocation: Blue Bell Pa.Direct Reports: TBDPosition Summary:To oversee the implementation of Quality Management System (QMS) for Henkels & McCoy and execution of the organization's long-range strategy regarding Quality. To develop, implement and audit quality policies and processes in compliance with industry standards and client requirements.Primary Outcomes:To develop, implement and maintain the H&M Quality Management System that achieves H&M's strategic and operational Quality goals as established in the H&M strategic planning process.To establish H&M's Quality Management System as a customer and industry recognized value addTo support the H&M regional field operations in the delivery of superior Quality work for the company and customer.Major Job Elements:*Manage the development, implementation, and maintenance of Quality Management System in compliance with applicable industry standards (i.e. ISO).* Work with senior management to strategically develop and align Quality Management System priorities and activities.* Communicate the H&M Quality principles and practices throughout the organization and ensure alignment with strategic objectives and work with regional operations and corporate departments to ensure effective implementation of Quality Management System.* Interface with large clients and work closely with project teams to develop and deploy project specific quality plans that comply with contractual quality requirements and deliver customer satisfaction.* Work closely with Continuous Improvement Managers to integrate quality processes and continuous improvement methodology based on Lean principles and practices focused on customer value, employee engagement, process standardization, built-in-quality, waste elimination, and continuous improvement.* Conduct industry research regarding Quality and Quality Systems to insure Henkels & McCoy's remains current in the area of Quality.Qualifications:Knowledge, Qualifications & Experience*4 year Bachelor's degree* 5 years experience in a Quality Leadership or Quality professional position required* 5 years experience in the construction industry / utility infrastructure a plus* In-depth understanding of quality principles and practices, and industry standards (ISO)* Experience with Continuous Improvement using Lean tools a plus* Experience with Environmental regulatory compliance and management a plusCompetencies & Skills:*Effective Communication (writing, presenting, listening)* Program Management (organizing, planning, executing)* People Skills (coaching, building teams, leading change)* Process deployment (design, training, implementation, control)* Customer Satisfaction(helpful, action-oriented, reliable)Henkels & McCoy, Inc is an Equal Employment Opportunity and Affirmative Action Employer
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Company: Aetna Location: US-MD-Linthicum Loading Map... Base Pay: $50,000 - $70,000 /Year Other Pay: Employee Type: Full-Time Industry: Healthcare - Health Services Manages Others: No Job Type: Nurse Reqd Education: 4 Year Degree Reqd Experience: At least 3 year(s) Reqd Travel: Not Specified Relocation Covered: No Reference ID: Register to View 1024 a Contact: Not Available Phone: Not Available Email: Send Email Now Fax: Not Available a company overview Aetnais one of the nations leading diversified health care benefits companies, serving members with information and resources to help them make better informed decisions about their health care. Aetna offers a broad range of traditional and consumer-directed health insurance products and related services, including medical, pharmacy, dental, behavioral health, group life, long-term care and disability plans and medical management capabilities. Our customers include employer groups, individuals, college students, part-time and hourly workers, health plans and government-sponsored plans.Visit our Website Quality Management Consultant Report It job description ABOUT OUR COMPANY We are a company built on excellence. We have a culture that values growth, achievement and diversity and a workplace where your voice can be heard.-Participates in the development and ongoing implementation of QM Work Plan activities. * Improve quality products and services, by using measurement and analysis to process, evaluate and make recommendations to meet QM objectives.* Performs data analysis for HEDIS department. a-Must be knowledgeable regarding HEDIS measures, prefer RN with informatics background a-Will communicate with providers (telephonically and through in-person visits) * Conduct presentations to providers and staff To view aaAetna Nurse Video and read our FAQs aboutabeingaa nurse at Aetna, please go to www.aetna.com, click onaCareers,aExperienced Professionals and SelectaNurses.a Oraclick on the link below: http://www.aetna.com/about-aetna-insurance/aetna-careers/experienced_nursing.html ajob Requirements The highest level of education desired for candidates in this position is a Bachelors degree or equivalent experience. LICENSES AND CERTIFICATIONS * Registered Nurse (RN) is desired * Certified Professional in HealthCare Quality is desired * Certified Business Analysis Professional (CBAP) is desired FUNCTIONAL WORK EXPERIENCE * HEDIS data analysis experience * Informatics background preferred * Nurses: Quality Management * Quality Management: Quality Management* Strong Excel and database knowledge * Excellent communication skills * Ability to prioritze * Strong clinical background desired aWe value leadership, creativity and initiative.a If you share those values and a commitment to excellence and innovation, consider a career with Aetna. We conduct pre-employment drug and background testing. Aetna does not permit the use of tobacco related products or drugs in the workplace. No agencies, please. a Aetna is an Equal Opportunity/Affirmative Action Employer. M/F/D/V Aetna is committed to maintaining an environment in which all employees are treated equitably and given the opportunity within the context of the business to achieve their potential. Aetnas Affirmative Action responsibilities extend to women, minorities, persons with disabilities and veterans. Company policy also provides for equal opportunity for qualified individuals regardless of race, color, sex, national origin, religion, age, disability, veteran status, sexual orientation, gender identity or marital status. No search firms please. a aReport ItPlease refer to job code -J3H2B367Y3K33DZ01TD when responding to this ad.
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Quality ManagerLocation: Manassas, VAJob Code: 453# of openings: 1DescriptionBe Part of the Next Generation of FlightAurora Flight Sciences is a leader in unmanned aerial systems, with a fleet of innovative aircraft designed to empower small tactical units, and safeguard our borders. Aurora provides the capabilities and process controls of a large company with the "can do" attitude of a small company.Ifyou feel you are qualified, apply for this position, it could change your future.Job Description:The Virginia Quality Manager is the primary oint of contact on and chief administrator of the AS9100 certified Virginia Quality Management System (QMS). The role encompasses but is not limited to the following expectations:Job Qualifications (basic job description):* Sustain and continuously improve the AS9100 certified QMS. Monitor and analyze customer experiences for facility QMS capabilities, develop strategies for implementation and growth, and tactically manage to successful conclusion. Maintain an effective equipment Calibration program.* Develop, document, and manage the FAA Airworthiness, Quality and Conformity processes associated with our aircraft development programs. Proven experience with and knowledge of 14 CFR 23, 43, 145 and other specifications as may be required. FAA Designated Airworthiness Representative (DAR) preferred.* Develop, document, and manage the Virginia internal audits and FOD prevention program to be effective and productive.* Develop, deploy and continuously improve the variety of performance metrics necessary to an effective QMS and for the programs benefit. Analyze data for trends, etc. and make improvements to processes.* Administration of the assigned inspector resources and the Material Review Board (MRB) as required.* Apply Quality Engineering principles, including statistics and predictive analysis, to conduct failure and/or pre-emptive analysis. Evaluate new products and processes as part of customer-focused design review teams.* Administer the Corrective Action Board (CAB) efficiently as part of an effective Corrective Action/Preventative Action (CAPA) program.* Primary administrator of the corporate quality manual QAM-001.* Establish, maintain, and enhance positive customer and supplier relationships to build a cooperative environment influential to both existing contract performance and new contract negotiations. Responsible to interface with customers and/or suppliers on all AVA quality topics.Aurora Flight Sciences is an Equal Opportunity Employer
Job Title: Material Runner/Quality Control Manager Wanted ASAP
Company: Location: Baltimore, MD
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Expanding residential construction company seeking person to deliver miscellaneous construction materials from our storage warehouse and home depot to various projects. When materials are not needed for delivery applicant will visit various projects and inspect to ensure quality. No consturction experience necessary. Apllicant must have a pick-up truck.