Job Description
A Power Builder developer responsible for building Power Builder applications using SQL Server, Web Services with SOAP and other standard technologies. The primary responsibility will be to work as a Power Builder and SQL Server programmer. The developer must coordinate with the rest of the team working on different layers of the infrastructure. Continuous communication for collaborative problem solving, sophisticated design, and building a quality product is essential. SAP integration skills is a plus.
Responsibilities
Build the new feature for label printing using PowerBuilder, Web Services and SQL Server.
Build maintainable, efficient, reusable, and reliable code
Ensure the best possible performance, quality, and responsiveness of applications
Identify bottlenecks and bugs, and devise solutions to mitigate and address these issues as needed.
Maintain code quality and organization.
Create documentation to describe the build, installation, source control and deployment processes.
Strong development experience of Power Builder 2017 and web services is a must.
Strong development experience with Microsoft SQL Server and other data connectivity frameworks is a must.
Strong understanding of object-oriented programming.
Ability to interact and work closely with several business unit and technical teams.
Working knowledge of .NET and C# programming.
Ability to write clean, readable and easily maintainable code
Understanding of fundamental design principles for building a scalable application
Experience creating database schemas that represent and support business processes
Proficient in unit testing the developed code.
Source: Job Diva – Job Listing
Responsibilities
Skills
Source: Job Diva – Job Listing
Responsibiltiies
Skills
Extensive knowledge and experience on
Source: Job Diva – Job Listing
Responsibilities
Source: Job Diva – Job Listing
Position Purpose:
Documentation and Training Specialist is responsible for supporting the activities of the Doc Center and Training Departments in Fort Worth North site. Maintain records of training documentation according to organizational regulatory requirements to include long-term and short-term temporaries, contactors, consultants and vendors. Maintain Validation Library documents according to organizational regulatory requirements including electronic records.
Major Accountabilities:
Review training records to ensure that training is current and properly documented, in accordance with regulatory requirements.
Identify deficiencies versus training plans and ensure corrective actions are implemented promptly
Manage projects as assigned to ensure all activities are completed as required
Administration of Validation/Library Documents
Following procedure governing Validation and QA documentation
Maintain Plateau Training system for Administration and QA Labs and other non-production groups at the FWN facility
Maintain the Validation Documentation Library in an orderly and timely manner
Support generating new Validation numbers for the site
Create/Enter records
Update profiles, curricula, and training plans
Assist New Temporary Training (NTT)
Assist in site audits
Assist in production board meetings
Key Performance indicators:
Library is maintained orderly and timely
Timely completion of training plans
Effectiveness of training
Training documentation current
Specific Professional Competencies:
Valdoc system entry/create/retention
CPDS Administration
DCM system back up support
Plateau Administration
Source: Job Diva – Job Listing
Monitor and/or perform inspection and control of products and materials. Perform product and/or component inspections in accordance with specifications and SOPs. Samples, inspects, and releases components and raw materials as per SOP.s and specifications. Monitors various stages of processing along with the appropriate paperwork in compliance with specifications. Maintains raw materials, in-process and finished goods retain storage areas. May conduct simple testing in accordance with defined standard operating procedures. Contact with outside vendors as necessary. Filing and archiving study related documents, includes lifting of boxes (25 lbs/11 kg to 40 lbs/18 kg). Demonstrated ability in the application of the requisite skills to perform the required tasks of the position. Receives general instructions on routine assignments under general supervision. Receives detailed instructions on new work, which may be closely supervised and reviewed. The work environment characteristics described here are representative of those an employee to encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Job has potential for biohazard exposure.. Years of Experience: 0 – 3 Years
Source: Job Diva – Job Listing
Working under the direction of the Production Manager or Supervisor, the incumbent is responsible for supporting the production of quality sterile filtered products to meet the production schedule, which includes cleaning and preparation of processing equipment, maintaining the inventory of supplies and general housekeeping duties. Responsibilities include integrity testing of filters, preparation and sterilization of processing equipment, and coordinating task and schedules within the group and across functional lines. Due to business needs, it may be necessary to work overtime including nights and/or weekends.
Skills include high degree of technical/mechanical aptitude: ability to function in a team environment; ability to operate computerized equipment; ability to function in a fast-paced environment; excellent interpersonal skill; and the ability to learn aseptic compounding procedures.
Must haves:
Ability to follow rules continuously
Very close attention to details
Eager Learner
Ability to manage time well
Ability to work under pressure
Completes the job correctly not just quickly
MUST be able to prioritize tasks and make sound judgment calls
Self-motivated – interested in a growing their career (starting from the middle and working their way up)
*Computer Proficient*
Source: Job Diva – Job Listing
Resource justification / benefit
Ensure on time compilation and dispatch of all country specific information for submission to all global markets, regular follow-up with affiliates to ensure timely submission by then to their HAs. Work with SMEs to ensure timely response to any global HA specific questions to facilitate timely approval of this supply critical submission.
Having a focussed resource project manage all global country specific requirements and constant tracking of dispatch, submission and approval timelines, will reduce likelihood of any delays for this submission, particularly markets with longer HA review timelines. More submissions can be managed in parallel, allowing the core team focus on major market submission & approval (critical for those markets that have major market approval as a pre-requisite for filing).
Role description:
Stage 1: Pre-submission
Interact with regional and local affiliates to collect regulatory information
Set up and manage project meetings with local affiliate as needed
Compile regulatory requirements to ensure completeness and clarity
Communicate with core project team for status update
Support core team in the maintenance of global filing plans
May assist with the planning and preparation of interactions with regulatory authorities by project managing preparation of meeting documents, internal prep meetings
Stage 2: Submission
Manage and update the global filing plan
Assist with collecting documents necessary for country specific submissions (SOPs, COAs, Manufacturing Authorizations, notarized documents, declarations, CPPs, etc)
May address questions and requests from regional and local affiliates
Track the progress of submissions by getting updates from affiliates
Assist with responses to questions from Health Authorities by setting up team meetings, as needed, project manage getting responses written, reviewed and content finalized
Report to the core team of progress of submissions and communicate submission risks
Source: Job Diva – Job Listing
Expertise with RT-PCR and qPCR are essential requirements, as well as experience in an oncology or immunology setting.
Primary Job Responsibilities: Mammalian cell culture experience and RNA/DNA extraction from cell lines Execute RT-qPCR protocols and prepare samples for sequence analyses Detection and quality analysis of RNA Conduct molecular and cellular biology experiments for compound screening or mechanistic pathway analysis using human and mouse cell lines Work closely with senior/principal scientist and group leaders to execute experiment protocols Record all data and results in specified forms (both electronic and paper) with accuracy and timeliness. Upload biology data into company database in vitro and/or cell-based drug screening assays Help maintain equipment and assist in ordering laboratory supplies Ensure that all safety guidelines are strictly followed at all times and maintain a clean and orderly work environment Summarize data in an organized and presentable fashion
Primary Job Requirements: B.A., B.Sc., or M.Sc. with 2+ years laboratory experience Experience in tissue culture of cancer and/or immune cells is required Basic laboratory skills in molecular and cell biology is essential and experience working with small molecules in a drug discovery setting is highly desirable Ability to work in a fast-paced, dynamic work environment on an interdisciplinary team Must have excellent written, communication, and presentation skills Ability to prioritize assigned work in order to meet regular timelines
Source: Job Diva – Job Listing
Summary:
The Senior Manager Statistical Programming (Health Outcomes, Value Assessment and Analytics, HOVAA) will provide leadership in programming, analyzing and managing real world evidence (RWE), market and business research and clinical trial studies, and as needed, provide expert-level hands-on support to programmers. The position requires a comprehensive and detailed understanding of observational research in health economics and outcomes, business and market research, clinical trials, and industry best practices, with utilization of large secondary databases such as claims and EHR/EMR sources and phase III/IV clinical trial data, and business and market data. The individual in this position is an expert in statistical programming languages, including SAS, SQL, and R. The manager will also perform statistical modeling by applying various methods (eg, propensity score matching, survival analysis, time-series analysis, logistic, poisson, gamma, mixed-effect regression, tree-based regression, etc.) to address business questions via analysis of RW outcomes and clinical trial health endpoints. This individual will assist in the design and development of RW studies (comparative effectiveness, patient disease journey, clinical/economic burden of illness, disease incidence/prevalence, trend of healthcare facility types) and be responsible for programming in numerous data processing steps (cleaning, extracting, merging, etc) in SAS/SQL/R programing environments and applying statistical methods to the studies. The individual will also learn new analytical methods and subject matters as needed.
Essential Duties & Responsibilities:
Interaction:
This role interacts with HOVAA, market access, commercial operations and strategy, payer and employer relations, business development and clinical study teams, data and statistical programmers, biostatisticians, project management, IT and external vendors.
Education and Experience:
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge, Skills, and Abilities:
Source: Job Diva – Job Listing
This position is %Remote___10%______ % On Campus__90%_________
The primary scope of this role is to ensure production attainment through technical troubleshooting, process controls, equipment maintenance, and technician support.
Responsibilities will include but are not limited to the following:
Process ownership to ensure manufacturing processes remain in a validated state and yields products that adhere to all specifications, requirements, and controls
Technical ownership to perform formal and/or informal root cause investigation and corrective action of product, equipment, material, or process mon-conformances, anomalies, observations, etc.
Technician support- Availability to technicians to answer technical questions, provide guidance, and receive feedback.
Identifies and implements initiatives that improve customer facing quality, reliability, or cost reduction.
Identifies and implements initiatives that improve manufacturing yield, cycle time, supplier performance, flow, operator safety & ergonomics, process simplicity, clarity, repeatability, and robustness
Provides on-going oversight and assurance that production equipment is properly maintained, safe, and in a state of control at all times
Serves as a subject matter expert at specific product development phases for DFM, process development, and capability assessment reviews.
Minimum 1+ years experience in an engineering role within Medical Device Operations or Manufacturing environment
Source: Job Diva – Job Listing
The Compliance Specialist uses expert knowledge of Compliance and GXP to manage Investigations and CAPAs within Engineering and Facilities. This position is responsible for performing a variety of complex tasks under general guidance and in accordance with current GMPs.
Basic Qualifications
Bachelors Degree with 3-5 years of experience
Knowledge of Biologics Manufacturing and Engineering
Understanding of GXP and how it applies to specific responsibilities
Excellent written and verbal English language skills
Experience in cGXP manufacturing environment
Experience in troubleshooting, investigating, root cause analysis and technical writing in a GXP environment
Ownership and Management of Deviations, CAPAs, Effectiveness Reviews and Change Controls
Preferred Qualifications
Bachelors Degree in Biology, Chemistry, Biochemistry or Chemical Engineering
Clean Utility Experience
Validation Experience
Facility Maintenance Experience
Special Working Conditions
Ability to gown and gain entry to manufacturing areas
Source: Job Diva – Job Listing
Summary:
Perform tasks under the guidance of project lead or departmental principals on analytic design and statistical analytic planning, coordinate real world database management, and data warehouse construction or maintenance.
Develop documentations of analytic plans, prepare for statistical concept communications and be able to advise on analytic strategies and recommend methodological solutions on complex analytic topics.
Lead and perform statistical analyses, modeling, reporting, analytic interpretations, and slide development.
Develop SAS macro libraries to standardize disease identification, cohort constructions, mapping of healthcare resource utilization and expenditures to standard metrics for product value propositions.
Construct drug coding systems to support database activities for key therapeutic R&D and brand LCM activities, and establish and maintain a repository of the coding systems for therapeutic medications, diagnostic or surgical procedures and drug delivery systems.
Establish and main variety of disease identification and composite comorbidity assessment tools and algorithms. Conduct analytic quality assurance procedures.
Provide timely analytic support for abstract and manuscript development and submissions to medical/scientific congresses or publications.
Provide analytic support for internal and external communications and statistical interpretations of data under the guidance of departmental methodological principles.
Develop statistical analytic plans, statistical expertise and data management techniques and skills.
Manage real world database operations, analytic programming and statistical modeling activities.
Assist project lead or departmental principals in study design, power calculation, CRF construction, analytic operations and reporting for retrospective and prospective studies.
Assist project lead or departmental principals in analytic/computing resource planning, work flow management and prioritization, and related logistic coordination.
Prepare communication materials on analytic projects including processes, data, analytic findings for internal and external functional groups within or outside.
Prepare slide decks for congress or manuscript submissions or internal or external communications.
Plan and initiate analytic projects using the real world databases or clinical trial data warehouse in support of the initiatives.
Provide consultation for all groups on research methodology and statistical or analytic issues.
Vendor Management. Database licensing and maintenance.
Analytic process formulation and standardization.
Potentially supervising team of analytic and programming support.
Years of Experience: 6 – 9 Years
Source: Job Diva – Job Listing
Responsible for designing, developing, and updating required technical documentation. Responsible for technical writing/editing for all types of documentation produced within a modern software development environment. Utilize knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality. Document programming standards and procedures. Track and review change control documentation. Assist with the editing of quality documents (SOP’s, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements. Must be able to work quickly with a high degree of accuracy. Must possess sound interpersonal and information gathering skills, be able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others. Review current documents- incorporate comments from Manager. Navigate through *** pasteur Geo (Documentum) system utilizing current templates. Notify manager of workflow status and issues. Incorporate comments from team members and provide status to manager on review and approval workflow. Follow up with team members on comments.Skills: Technical writing abilities and good time management. Strong root cause analysis skills with experience regarding quality standards. Be able to establish working relationships with other support and production areas in order to gather all the necessary information required. Must be proficient in Geo with a working knowledge of templates, workflows and approval process. Proficient in MS Word, Excel, Powerpoint and Outlook. Interact well with a diverse group of individuals. Self-motivated and willing to be proactive in resolving issues. Excellent Verbal and written communication skills. Ability to work in a team environment.Education: University graduate preferred. Secondary Education diploma a requirement.. Years of Experience: 0 – 3 Years
Source: Job Diva – Job Listing
Clinical Data Manager, Oncology
Perform Access Management activities : Perform activities in providing access to different clinical systems and performing review of access using listings.
-Perform DM activities for in-house and outsourced trials: protocol review, CRF development, database set up activities, data validation process (including manual data review of listings), managing local laboratory and external labs and database lock.
-Perform Project Management : represent DM on clinical teams, coordinate deliverables by other functions and/or CRO as necessary to achieve DM deliverables.
-Coordinate with Programming team to provide support to the data review and safety updates (coordinate generation of data review listings, data retrieval to support data review and analysis, SDTM,)
-Coordinate CRO data validation activities (coordinate data transfer specs, data reconciliation, query generation and resolution)
-Participate in the development and implementation of department standards and documents, and other data management, departmental activities as needed.
Bachelor degree or above in scientific or related field Minimum 1-3 years experience in Data Management with experience in managing projects, project teams. Experience with In-Form or other EDC software is desirable however, should have some experience in supporting Oncology studies. Must be able to work independently. Proficiency on all related regulations, GCP, and Good Clinical DM Practice. Project management skills required. Strong oral and written communication skills.
Source: Job Diva – Job Listing
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