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New York, New York, Position Summary: The Analyst Summer Internship is an  intensive 40-weeks program  within the Trading and Strategy Investments team who is responsible for a variety of strategic investment strategies with a focus on a disciplined return on investment methodology. The Intern will gain valuable experience in  market and economic   data sourcing,  large data analysis and synthesizing investment information with key focuses related to portfolio construction and theoretical application of investment ideas to implementation and trading on those investments. All while learning about insurance asset manager and the industry, company and their financial, economic market analysis; whilst supporting and developing investment trends and economic infrastructure. Strong emphasis on U.S. and introduction to Japan capturing a variety of institutional and industry specific  concepts to help inform investment professionals.  The Intern will benefit from  exposure to IFG CORPORATE ACCOUNTING SERVICES platform  with emphasis on macro-economic data used across portfolio with an emphasis on fixed income, understanding investment risk management and economic undercurrent, and leading up to how data is assembled and presented to key stake holders. The Intern will  interact with Senior Management  and will present their analytical project(s) to an audience of key stakeholders including other investment professionals, analysts, traders, portfolio managers, and Senior Management. Responsibilities: Our summer interns participate in a series of activities that provide the opportunity to learn about all areas of the firm, as well as on-the-job training in portfolio analytics and surveillance. The intern will be assigned projects in support of current business needs including research and analyst responsibilities within the credit portfolio for the full 10 week period. Communicate regularly with all aspects of an insurance asset manager with emphasis on relevant news, regularity of information, interpretation of information, data analytics and the potential risks, while developing methodology for presenting ideas in a thoughtful manner. Learn how to research and correlate investment ideas and supporting analytics to develop an assessment within defined data sets, industry analysis; along with identifying key trends and movement within financial markets. Create and maintain large data sets, while identifying key trends and statistical information to guide stakeholders in aiding in investment decisions. Participate in the design and implementation of investment analytics pertaining to the assessment and management of the company’s investment strategies and risks, including but not limited to stochastic financial projections, understanding tail event stress testing, regulatory capital modeling, portfolio optimization, performance attribution, along with developing asset understanding in foreign exchange and derivatives. Opportunity to significantly contribute to and influence the development of the company’s next-generation investment platform. Interact collegially and professionally with other members of the trading and quantitative, strategy, and research groups as well as well as other departments such as Credit, Portfolio, External Management, Enterprise-Wide Risk Management, Accounting, Actuarial, Tax, IT, HR, etc. Write industry reports as needed. Participate company /department wide meetings throughout the summer. Compile and maintain company and industry relative value analysis. Written and verbal presentations to assorted stakeholders Qualifications: We seek highly motivated student whoa re eager and willing to learn and have a strong interest in investments, finance, asset management, economics, insurance, and our company. Additional qualifications include: GPA of 3.5 or above preferred Degree Focus: Finance, Statistics, Economics, Data Analytics, or similar degree programs. Excellent analytical, quantitative, and problem solving skills Strong verbal and written communication skills Demonstrated leadership, interpersonal, and relationship management skills Basic understanding of financial statements Intermediate to advanced proficiency with MS Excel, Word, and PowerPoint. The above salary is monthly.

Nationwide, Qualified Data Systems has an immediate need for several experienced Software Quality Assurance consultants (SQAs). We are looking for SQAs with direct experience in the Medical device,  Pharma or Biotech Industries, to join the QDS team on an active project being conducted remotely.  The SQAs primary function is providing technical consulting guidance and expertise to customers. Responsibilities for the SQA role include: Provide guidance for quality and compliance activities Development and implementation of System Development Life Cycle Processes from technology acquisition to system retirement. Lead project teams focused on delivering Governance, Risk, and Compliance services providing hands-on consulting experience to project teams in system selection, acquisition, specification, configuration, design assurance, implementation, integration, and maintenance. Provide technical evaluations of Enterprise Applications including Embedded Devices, Standalone Applications, Middleware, Databases, Cloud Infrastructure, and IT Networks. Leads in requirements elicitation and detailed design discussions with software developers, software analysts, R&D, hardware engineers, software architects, program managers and quality/regulatory personnel. Analyzes business processes using advanced Data Analytics tool Qualifications Bachelors’ degree in Electrical Engineering, Computer Engineering, Computer Science, or similar engineering discipline including Software Engineering or Biomedical Engineering Must possess direct experience within manufacturing, business, or laboratory environments. Experience in IT Compliance within the regulated Life Sciences is needed. Must have direct experience with regulatory compliance guidance including FDA 21 CFR Part 820, ISO 13485, ISO 14971, General Principals of Software Validation, Electronic Records/Signatures Desired experience with Industry guidance including NIST 800-53, IEC 62443, IEC 27001, IEC 29100, IEC 17799, GAMP, GDPR, Data Integrity Experience with secure software & firmware design, architecture, coding, trusted manufacturing, and trusted supply chains Experience in designing and performing quality & compliance risk assessments Certifications desirable: CISA, CRISC, CGEIT, CISSP, GSSP, CSSLP, SSCP, CIPP, CSQE, CQA Experience with software development methods, secure development lifecycle (SDLC), security-by-design, change management, contingency planning, and disaster recovery Total Combined Experience: 5+ Years Please do not apply if you have no Software Quality experience. Individuals with no software experience will not be considered.

Buffalo, New York, POSITION OBJECTIVE: Manage Quality Control Chemistry personnel and laboratories. Manage Incoming Quality Control personnel and areas. Oversee Quality Control (Chemistry and IQC) Metrics, Investigations, Product Development Activities as related with QC, Product Release and Continuous Improvement. Essential Job Functions/Responsibilities Oversee Quality Control Chemistry testing for In-Process/Bulk, Finished Product, Raw Materials, and Stability at multiple sites. Oversee Incoming Quality Control personnel and areas at multiple sites. Provide cGMP guidance and training to laboratory personnel regarding FDA guidelines, USP and other compendia, GXP, ICH, and EMEA. Setup and maintain efficient laboratory systems and processes for increasing manufacturing output and additional sites/locations. Ensure QC laboratories are in state of compliance and are inspection ready. Ensure a safe work environment for laboratory personnel with compliance to OSHA requirements. Provide review and approval of laboratory data, specifications, performance verifications, certificate of analysis, and no-test forms. Conduct laboratory investigations, discrepancy investigations, environmental excursions, out of calibration reports, and CAPA in a timely manner. Manage personnel, support departmental budget planning, develop, and maintain Quality Control testing schedules, and instrumentation vendor services. Create, Revise, and/or Review operational SOPs, technical documents, protocols, and reports. Promote and implement staff training, motivation, and personnel development. Complete staff assessments and performance reviews as required ensuring competencies are maintained. Participate in personnel development programs to further enhance skills and knowledge relevant to the position. Provide input into continuous improvement and metric development and maintenance. Serve as SME and provide guidance for method transfers, method qualifications and ICH guidelines, validation activities for UHPLC and GC, and compendial testing. Interacts with other function groups for projects planning and QC requirements. Review and approve analytical procedures, specifications, and method development. Provide a fair assessment and execute processes in hiring new staff members. Provide support for customer and manufacturing related needs while maintaining a high level of professionalism. Support analytical needs that occur on off-shift hours and multiple sites. Review and approve new equipment protocols and method validation, qualification, and transfer protocols. Interface with all regulatory agencies and customer audit representatives. Prepare quotes and budgets for the QC department as needed. Serve as QC SME during regulatory inspections, internal audits, and customer audits. Required Education & Qualifications B.S. or advanced degree in an applicable life-science with a minimum of 5 years of experience in the pharmaceutical manufacturing industry or an Associate degree in an applicable life science with a minimum of 10 years of experience in the pharmaceutical manufacturing industry. Proven capabilities in reviewing and approving analytical procedures, specifications, analytical method transfer reports, and method development reports. Strong leadership with experience in managing, supervising, and developing employees and teams. Excellent verbal and written communication skills. Ability to effectively communicate and collaborate with multiple levels within the organization to achieve measurable results. Strong focus on quality and safety in a laboratory environment. In depth knowledge and experience with cGMP 21 CFR 210/211/820 Quality Systems. Working knowledge of laboratory information management systems (LIMS) and experience in leading LIMS implementation and optimization. Advanced knowledge and implementation of data integrity principles. Advanced organizational and time management skills. Experience and involvement with regulatory inspections as well as internal and external audits.     Salary commensurate with experience

INFORMS Journal on Computing, Ahead of Print.

INFORMS Journal on Computing, Ahead of Print.

INFORMS Journal on Computing, Ahead of Print.

INFORMS Journal on Computing, Ahead of Print.

INFORMS Journal on Computing, Ahead of Print.