Corporate Investigator 4
Lancesoft job in Berkeley, MO
This job is with Encode, Inc a fully owned subsidiary of Lancesoft This position is part of the Law and Global Compliance organization, and works with a shared purpose and alignment to Corporate Investigations Strategy. Position Responsibilities: Gathers preliminary investigative data (e.G., witness statements, electronic data, physical evidence) to assess the validity of an allegation
•Prepares an investigative plan to issue spot, determine investigative scope, as well as to identify and employ additional resources (e.G., budget requirement, special equipment, computing forensics)
•Utilizes established investigative procedures to continually assess reported information to determine risk and whether it is within the investigation scope of responsibility
•Investigates complex matters and evaluates compliance to policies, procedures, and regulations by gathering data and employing subject matter experts to understand the facts and draw conclusions
•Strengthens the Company's anti-retaliation efforts by identifying and investigating retaliatory behaviors, and by reassuring investigative participants of anti-retaliation protections
•Strengthens investigative partnerships with Ethics, Human Resources, Law, Quality, Safety, and others through alignment, and understanding of joint investigations
•Briefs stakeholders (e.G., Reporting Party, Human Resources, Management, Ethics) periodically on case status, as well as relevant findings during the course of the investigation on a need-to-know basis as determined by the sensitivity of the investigation or as mandated by the Law Department
•Creates a concise written report detailing the factual outcome of the investigation, as reported in the electronic case management system, by using an approved standardized format
•Advises concerned parties of investigative findings (e.G., Law, Ethics, Human Resources, management for follow-up action/adjudication/documentation) ••Identifies and records factors that contribute to wrongdoing
•Assists in reducing the likelihood of future wrongdoing by identifying remediation opportunities
•Mentors, trains, and works alongside other investigators to ensure knowledge transfer
This position is hybrid. This means that the selected candidate will be required to perform some work onsite at one of the listed location options. This is at the hiring team's discretion and could potentially change in the future. The selected candidate must be able to respond to their assigned work location in a timely manner in order to address exigent business needs. Some travel to other work locations may also be required.
Basic Qualifications (Required Skills/Experience):
•5+ years of experience conducting complex investigations and managing the investigative process to include conducting interviews, collecting data and facts, preparing concise and accurate reports, and analyzing data to identify trends and/or discrepancies
•5+ years of experience with Microsoft Office Products like Outlook, PowerPoint, Excel, and Word
Preferred Qualifications (Desired Skills/Experience):
•3+ years of experience in conducting formal employee-related investigations
•3+ years of experience conducting EEO investigations and determining a resolution
•3+ years of experience conducting alleged misconduct investigations of union represented employees Proficiency with case management systems, previous experience as a subject matter expert, and use of forensic investigative tools and software
•Certified Fraud Examiners (CFE) certification or Leadership Professional in Ethics and Compliance (LPEC) and/or other relevant certification in compliance or workplace investigations.
Shift Work: This position is for 1st shift but may occasionally need to support 2nd or 3rd shift.
Typical Education & Experience: Education/experience typically acquired through advanced education (e.G. Bachelor) and typically 10 or more years'related work experience or an equivalent combination of education and experience (e.G. Master+8 years'related work experience, Bachelors+14 years'related work experience, etc.)
Manufacturing Technician
Lancesoft job in Saint Louis, MO
3rd shift - Mon, Tues, Wed, and Thurs (10 hour shifts) 10pm 8: 30am the next day. (4 x 10) Training will be on first shift for 2-3 months. Monday-Friday 6am-2: 30pm. Title: Manufacturing Technician 2 Pay: ***+ 10% shift differential Temp to perm potential
SAP experience
100% on-site
Some college/Associates would be preferred
Aseptic Technique experience
Timeliness and punctuality is a must
Osmometer or pipetting experience preferred
Steel toed shoes
Interviews will be on-site
Your Role:
The Manufacturing Technician 2 at the Broadway site is responsible for setting up and preparing products according to current manufacturing procedures, cleaning up equipment and manufacturing suites after production operations, complete batch records during the production of products, and always follow all safety and quality policies. Just duties include:
Set-up and operation of processing equipment such as Filter Integrity testing, Watson Marlow pumps, Autoclaves, and High throughput Bag Line.
Delivers products to Warehouse via motorized pallet jack.
Perform production operations, such as, Hand fill, prepping fill equipment and Aseptic gowning and qualification.
Clean up equipment and working areas after production operations.
Coordinate appropriate disposal of waste and complete compliance documentation
Communicate the status of production operations/equipment and bring deviations to attention of supervisor.
Provide a complete and accurate batch record at the conclusion of production operations consistent with quality guidelines.
Execute batch records in SAP.
Ensure all applicable logbooks have been filled out completely.
Follow production procedures and safety policies at all time.
Use, clean, and store all personal protective gear appropriately.
Label all in process equipment and containers properly.
Take action and resolve any unsafe conditions.
Participate in safety and quality training activities.
Supporting all activities of Manufacturing Tech 1, communicate and document status processes, products, and equipment.
Perform In-Process assays.
Setup, dispense, and package technically challenging products.
Who you are:
Minimum Qualifications:
High School Diploma or GED.
Preferred Qualifications:
1 + years manufacturing experience.
Knowledge in chemistry, mathematics, and science.
Experience with safe chemical handling methods.
Effective oral and written communication skills.
Good computer, mechanical, troubleshooting, and organization.
Asset Administration Specialist
Saint Louis, MO job
BCforward began as an IT business solutions and staffing firm. Founded in 1998, BCforward has grown with our customers' needs into a full service personnel solutions organization. BCforward's headquarters are in Indianapolis, Indiana and also operates delivery centers in 20 locations in North America as well as India and Puerto Rico. We are currently the largest consulting firm and largest MBE certified firm headquartered in Indiana.
Job Title: Asset Administration Specialist
Job Location: SAINT LOUIS MO 63101
Job Duration: 6+ Months
Rate: $22.22/Hr
Job Description:
Manage asset inventory daily
Perform quarterly asset lease roll and return process for assets with expiring leases. Perform annual asset inventory validation
Research and locate missing AIC owned assets
Procure and track new assets
Coordinate account management / access credentials
Coordinate, manage and track shipment of assets and returns (e.g., laptops, photo badges, etc.)
Additional Information
Namratha Gandavarapu
************
Warehouse Operator
Lancesoft job in Saint Louis, MO
1 year minimum experience in warehouse and sit down forklift experience. Description:
Comply with and support GMP, Environmental, Health and Safety policies and procedures.
Use of forklifts and various other powered industrial equipment, unload inbound freight, verify packing slip, log material, and stage material in warehouse and GMP areas.
Data entry of finished goods produced, packaging components or raw materials received, and location transfers in the ERP (SAP) system. Print and apply pallet tickets on materials received.
Data entry and Master data entry in SAP.
SAP experience is a plus but not required.
Physical movement of packaging components and raw materials in warehouse locations using various powered lift equipment and prepare documentation of location movements.
Responsible for outbound shipment of finished goods. Inspect trailer, analyze load weight, pull, and load finished goods, complete shipping documents, and seal trailer. Also load trailers with inventory and non-inventory materials for destruction.
Perform safety checks and other routine PMs.
Assist in the development of OJT s (On the Job Training) and train others on departmental OJT s.
Load and operate various freight elevators to transfer materials from Warehouse to various GMP areas in the facility.
Pull and destroy rejected and obsolete material per local procedure. Participate in cycle count and/or physical inventory counting of materials.
Maintain warehouse cleanliness.
Ensure quality and compliance in accordance with established procedures and standards of the Quality System.
Audit Data Analyst
Lancesoft job in Chesterfield, MO
• Lead efforts in evaluating the efficiency and effectiveness of internal controls utilizing CAATs (Computer Assisted Audit Tools) based on the annual audit plan. In addition, prepare documentation and reports to communicate audit findings and recommendations to senior leadership under general supervision of the Director, Business Risk Services. Has a solid understanding of general controls, best practices, and business processes.
• Responsible for ongoing monitoring and support of the ACL infrastructure and contributes to the overall department wide goals and objectives. In addition, work with process owners to define, develop and execute data analytics and implement continuous monitoring to evaluate, support, and enhance business processes
• This includes leading efforts to define business requirements, identifying and extracting data, executing analyses, and preparing written documentation and deliverables. Performs duties and responsibilities in a manner consistent with our mission, values, and Client Service Standards.
Job Description Responsibilities:
• Lead efforts in evaluating the efficiency and effectiveness of internal controls utilizing CAATs (Computer Assisted Audit. Tools) based on the annual audit plan. In addition, prepare documentation and reports to communicate audit findings and recommendations to senior leadership under general supervision of the Director, Business Risk Services. Has a solid understanding of general controls, best practices, and business processes. Responsible for on-going monitoring and support of the ACL infrastructure and contributes to the overall department wide goals and objectives. In addition, work with process owners to define, develop and execute data analytics and implement continuous monitoring to evaluate, support, and enhance business processes. This includes leading efforts to define business requirements, identifying and extracting data, executing analyses, and preparing written documentation and deliverables.
• Manage Execution of Audit Process
• Assists in the execution of the annual audit plan. Drafting of the audit program, audit scope, and execution of audit steps Development of ACL scripts Performs the drafting of questionnaires and defining data requirements, etc. to assist in analyzing business processes and controls. Documentation of audit work performed Supervision of Business Risk data analyst, including review of audit work papers and input into performance reviews. Drafting of audit reports to summarize audit findings. Leads meetings to communicate findings to senior leadership. Provides on-going monitoring and reporting of remediation status.
Leadership
• Partner with the business on identifying recommendations to strengthen business processes and mitigate risks identified Takes responsibility for quality of work product. Identifies and shares relevant business and audit topics with the audit group.
Building Relationships
• Partners with management to identify constructive and value-added recommendations to address risks identified. Leads meetings for assigned audits Identifies opportunities for and participates in approved special projects, investigations or other significant business issues. Assist SRS co-workers in applying Information Systems audit concepts and in the use of audit software (e.g. ACL).
Administrative
• Wears proper personal protective equipment when appropriate. Observes universal precautions consistently. Wears clothing and Health System badge consistent with dress code, and attends to personal hygiene to maintain a clean, well-groomed appearance. Meets Health. System attendance standards. Performs related duties as assigned.
Licensure:
• Experience: Audit experience and/or experience with Computer Assisted Audit Tools (ACL) Certification/Registration:
• Other skills & knowledge:
• (skills, knowledge, abilities)
• Advanced knowledge of AuditExchange and scripting in ACL
• Strong analytical skills, interpersonal, organizational and oral/written communication skills Self-directed, and able to work independently
• Proven ability to meet goals and work at a high performance level
• Ability to work within a team environment and interacting with management
• Superior skills in the extraction, merging and transformation of large data sets across systems and databases environments; at least three years ACL experience required
• Data analysis skills, with experience in designing analytical approach/ methodology, identifying key findings, and producing output for a non-technical audience
• Experience using relational database platforms including SQL and Oracle required
Qualifications
Qualifications: MINIMUM REQUIRED
• Education: Four year college degree in Accounting or Information Systems/ Technology related field
Additional Information
PREFERRED
• Experience: Healthcare experience preferred
• Certification/Registration: Professional Certification (ACDA, CISA, CIA, CPA) or advanced degree preferred
Travel Nurse RN - OR - Operating Room - $2,300 per week
Lancesoft job in Saint Louis, MO
LanceSoft is seeking a travel nurse RN OR - Operating Room for a travel nursing job in Saint Louis,, Missouri.
Job Description & Requirements
Specialty: OR - Operating Room
Discipline: RN
Duration: 13 weeks
36 hours per week
Shift: 12 hours, nights
Employment Type: Travel
RN - Post-Op Extended Care | Nights | 3×12 | St. Louis, MO
• Unit: OR/Post-Op Extended Care
• Shift: Nights, Mon-Thu, 3×12 (36 hrs)
• Requirements: 3+ yrs exp, BLS, ACLS, EPIC
• Notes: No weekends/holidays, no call. Not a PACU role.
• Start: 12/15/2025 | 8 weeks
About LanceSoft
Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization. Lancesoft Inc. is one of the highest rated companies in the industry. We have been recognized as one of the Largest Staffing firms and ranked in the top 50 fastest Growing Healthcare Staffing firms in 2022. Lancesoft offers short- and long-term contracts, permanent placements, and travel opportunities to credentialed and experienced professionals throughout the United States. We pride ourselves on having industry leading benefits. We understand the importance of partnering with an expert who values your needs, which is why we're 100% committed to finding you an assignment that best matches your career and lifestyle goals. Our team of experienced career specialists takes the time to understand your needs and match you with the right job Lancesoft has been chosen by Staffing Industry Analysts as one of the Best Staffing Firms to Work for.LanceSoft specializes in providing Registered Nurses, Nurse Practitioners, LPNs/LVNs, Social Workers, Medical Assistants, and Certified Nursing Assistants to work in Acute Care Centers, Skilled Nursing Facilities, Long-Term Care centers, Rehab Facilities, Behavioral Health Centers, Drug & Alcohol Facilities, Home Health & Community Health, Urgent Care Clinics, and many other provider-based facilities.
Benefits
Weekly pay
Medical benefits
Travel Nurse RN - First Assist - $3,000 per week
Lancesoft job in Saint Louis, MO
LanceSoft is seeking a travel nurse RN First Assist for a travel nursing job in St. Louis, MO 63128, Missouri.
Job Description & Requirements
Specialty: First Assist
Discipline: RN
Duration: 13 weeks
40 hours per week
Shift: 8 hours, days
Employment Type: Travel
Job Title: RN - First Assist (Operating Room)
Shift: Days, 5x8 (Monday-Friday, 06:45-15:15)
Assignment Length: 13 Weeks
Position Overview
We are seeking an experienced RN First Assist to support our high-volume Operating Room. The ideal candidate will have strong General and Orthopedic OR experience, with a team-focused and adaptable approach
.
Certifications:
Required: BLS and ACLS (AHA only)
Preferred: RNFA certification, CNOR, Neuro OR experience
Experience:
Minimum 2 years of RNFA/CNOR experience in General and Orthopedic OR cases
Preferred Skills
Certification in First Assisting
Experience in Neuro OR procedures
Strong background in General and Orthopedic surgery
Unit & Facility Details Operating Rooms: 21 Cases per Day: ~60 Patient Population: Adult, Geriatric, some Pediatrics Equipment: Standard OR equipment, 2 Da Vinci XI robots, 1 ROSA robot, 3 Stealth navigation systems (Neuro/ENT) EMR: EPIC and Tecsys #HSHCNS
About LanceSoft
Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization. Lancesoft Inc. is one of the highest rated companies in the industry. We have been recognized as one of the Largest Staffing firms and ranked in the top 50 fastest Growing Healthcare Staffing firms in 2022. Lancesoft offers short- and long-term contracts, permanent placements, and travel opportunities to credentialed and experienced professionals throughout the United States. We pride ourselves on having industry leading benefits. We understand the importance of partnering with an expert who values your needs, which is why we're 100% committed to finding you an assignment that best matches your career and lifestyle goals. Our team of experienced career specialists takes the time to understand your needs and match you with the right job Lancesoft has been chosen by Staffing Industry Analysts as one of the Best Staffing Firms to Work for.LanceSoft specializes in providing Registered Nurses, Nurse Practitioners, LPNs/LVNs, Social Workers, Medical Assistants, and Certified Nursing Assistants to work in Acute Care Centers, Skilled Nursing Facilities, Long-Term Care centers, Rehab Facilities, Behavioral Health Centers, Drug & Alcohol Facilities, Home Health & Community Health, Urgent Care Clinics, and many other provider-based facilities.
Benefits
Weekly pay
Medical benefits
Network Engineer III
Lancesoft job in Granite City, IL
Network Troubleshooting, and Configuration Routing, Switch, Cisco experience More focus will be on troubleshooting than design aspect On call requirement Heavy industry exp. Is plus (Steel Industry exp. Will be preferred) Control systems (PLC) experience Self-Starter who requires limited direction
Travel within local area of the plant (Sometime may be to Gary IN).
IT Auditor/Security Analyst
Weldon Spring, MO job
BCforward began as an IT business solutions and staffing firm. Founded in 1998, BCforward has grown with our customers' needs into a full service personnel solutions organization. BCforward's headquarters are in Indianapolis, Indiana and also operates delivery centers in 17 locations in North America as well as Hyderabad, India and Puerto Rico. We are currently the largest consulting firm and largest MBE certified firm headquartered in Indiana. With 14+ years of uninterrupted growth, the addition of two brands (Stafforward and PMforward) and a team of more than 1400 resources our teams deliver services for multiple industries from both public and private sectors. BCforward's team of dedicated staffing professionals has placed thousands of talented people over the past decade, with retention rates that are consistently higher than the industry average.
Job Description
BCforward is seeking a highly motivated and experienced Security Analyst (IT Auditor)
Job Title: Security Analyst (IT Auditor)
Overview:
Our client builds and implements powerful solutions that help to drive and support the global operations of their brands and businesses.
There, you will be part of a team that creates and delivers leading-edge technologies and expansive systems that impact every aspect of our growing businesses. They provide the resources to enable and develop more than 2,000 innovative I.T. professionals in a variety of career paths. This is where it all starts. All systems GO!
Responsibilities:
Our client's Information Security Office has an opportunity for a Security Analyst Contractor. The Security Analyst Contractor will have responsibilities to participate in external/third party vendor security audits and risk assessments, and coordinate IT efforts to comply with security policies, standards and procedures. Strong communication skills are required as this role interacts with external partners and all levels of management across the organization. The individual will analyze system and application security and provide security recommendations for optimum protection of computer systems and information resources. This individual assists in identifying security risks and exposures by participating in security reviews, IT projects, evaluations and risk assessments to measure compliance with regulations, security policies and standards. The individual will represent the Information Security Office in meetings and communicate security standards to teams.
Additional Responsibilities:
Conduct vendor security assessments and compliance reviews
Conduct security reviews of information technology infrastructure and applications
Ability to translate information security policies into operational processes
Basic knowledge of published security standards (ISO, NIST, PCI)
Interface with IT and Business community on implementing controls for corporate and regulatory compliance
Equal Opportunity Employer - Minorities/Women/Veterans/Disabled
Qualifications:
Minimum Requirements:
2+ year's regulatory compliance experience conducting audits or risk assessments in large corporate environments.
Thorough understanding of IT infrastructure with 2+ years' experience in operating system, database, network or application security
Possess strong written and verbal communication skills
Possess strong analytical skills
Ability to organize and prioritize multiple assignments and tasks
Embraces the need to dynamically evolve and stay current in knowledge of the business, its technology and industry information security arenas
Ability to handle proprietary and sensitive information in a confidential manner
Preferred:
Bachelor's degree (Information Security or IT field) is preferred
CISSP and/or CISA certifications a plus
Experience with vendor management and 3rd party security assessments a plus
Location: Weldon Springs, MO
Contract length: Long Term
About BCforward
BCforward began as an IT business solutions and staffing firm. Founded in 1998, BCforward has grown with our customers' needs into a full service personnel solutions organization. BCforward's headquarters are in Indianapolis, Indiana and also operates delivery centers in 17 locations in North America as well as Hyderabad, India and Puerto Rico. We are currently the largest consulting firm and largest MBE certified firm headquartered in Indiana. With 14+ years of uninterrupted growth, the addition of two brands (Stafforward and PMforward) and a team of more than 1400 resources our teams deliver services for multiple industries from both public and private sectors. BCforward's team of dedicated staffing professionals has placed thousands of talented people over the past decade, with retention rates that are consistently higher than the industry average.
Additional Information
Must be able to pass a background and drug screen
Lead Applications/Java Developer
Lancesoft job in Sunset Hills, MO
Job Title: Lead Applications/Java Developer Type: 3 months Contract to Hire Responsibilities: Lead Java Developer with 8+ years of service, will be working on Spring/Hibernate based web applications BA/BS in Computer Science or related field STRONG Java OO experience required
Excellent Business Domain Modeling skills
STRONG communication skills
Preferred Skills:
Java 1.5/1.6
Angular
Spring
Hibernate & xmL
Oracle/MySQL
Design Patterns
SOA
JQuery
HTML/CSS
JavaScript
Web Services (REST/SOAP)
Additional Information
All your information will be kept confidential according to EEO guidelines.
Design and Analysis Engineer 2 Skill Code:664-Electronic Sys Design & Analy
Lancesoft job in Berkeley, MO
This job is with Encode, Inc a fully owned subsidiary of Lancesoft ·Assists with the development and documentation of electronic and electrical system requirements. ·Develops or modifies basic hardware and software designs based on defined requirements.
·Performs system tests to verify operational and functional requirements.
·Supports fabrication technicians and suppliers'questions during build and fabrication process
·Supports resolution of product integration issues and production anomalies.
·Supports hands-on troubleshooting of test racks
·Perform acceptance test procedures to demonstrate conformance to design and document results
·Develop and maintain scripts used to run test functions using C and C++
·Researches basic technologies for potential application to company business needs
This position requires the ability to obtain a US Security Clearance for which the US Government requires US Citizenship as a condition of employment.
·An interim and/or final U.S. Secret Clearance Post-Start is required.
Basic Qualifications (Required Skills/Experience):
·Bachelor of Science degree from an accredited course of study in engineering, engineering technology (includes manufacturing engineering technology), chemistry, physics, mathematics, data science, or computer science.
·2+ years of work-related experience with a Bachelors OR Masters Degree
Preferred Qualifications (Desired Skills/Experience):
·Strong problem-solving and debugging skills
·Experience with laboratory test equipment (oscilloscopes, logic analyzers, etc.)
·Excellent written and verbal communication skills
·Strong foundation in C, C++, and python
·Siemens Capital Experience
Bachelor's degree and typically 2 or more years'experience in an engineering classification or a Master's degree with experience in an engineering classification. Required: Bachelor of Science degree from an accredited course of study in engineering, engineering technology (includes manufacturing engineering technology), chemistry, physics, mathematics, data science, or computer science.
Sr. Regulatory Affairs Product Specialist
Lancesoft job in Hazelwood, MO
Established in 2000, A Minority Business Enterprise (MBE), LanceSoft Inc. is a pioneer in providing premium end-to-end Professional IT/Non-IT Contingent Workforce Solutions and IT Services to diverse clients across various domains.
Core Service Offerings
We offer a gamut of services across diverse domains, categories, skill sets with varying lengths of assignments, that include, but are not just limited to:
- Temporary Staffing
- Permanent Staffing
- Payrolling
- Recruitment Process Outsourcing (RPO)
- Back-office Services
- Application Design and Development
- Website Design and Development
- Program/Project Management
Our Domain Strength
With currently over 1000+ staff serving over 49 clients worldwide including “Fortune” companies, LanceSoft serves a wide array of industries including Healthcare/Pharma, Clinical/Medical Devices, Technology, Telecom, Retail and Distribution, Energy & Utilities, Banking, Finance, Insurance, Manufacturing, Automobile, Media, Transportation, and Government Sectors.
Geographic Coverage
LanceSoft is headquartered in Herndon, Virginia and has a network of branch offices across the US in Chicago (IL), Irving (TX), Basking Ridge (NJ), Atlanta (GA) and San Diego (CA). We also have an International footprint with two country offices in Canada (ON and BC) along with three delivery centers in India- Bangalore, Indore and Hyderabad to further help serve our clients better. We currently operate and recruit in 49 US states catering to diverse Contingent Workforce needs of our clients.
Awards and Accolades
Following are some of our awards and accolades in the US Contingent Workforce space:
- Manpower “Premier Vendor” - 2014
- Kelly's “Supplier Innovation Award” - 2012
- Kelly's “Supplier of the Year” Award - 2012 and 2011
- Kelly's “Service Excellence Award” - 2010 and 2009
- “Stewardship Recognition” from Johnson & Johnson's (J&J) Kelly Work sense program
Specialties
IT/Non-IT Contingent Workforce Services, Creative Solutions, Temporary/Permanent Staffing, Recruitment Process Outsourcing, Payrolling, Application Design and Development, Back-office Services, Program/Project Management, Website Design and Development
Job Description
Summary of position:
·
The Sr. Regulatory Affairs Product Specialist is responsible for developing and implementing regulatory strategies for assigned drug products throughout the product lifecycle in the Specialty Generics business of Client's. This position will help lead regulatory efforts to obtain approvals in order to market new generic drug products and provide ongoing regulatory support for all post-marketed projects and programs, ensuring maintenance and regulatory compliance of marketed generic drugs.
Essential functions:
·
Serve as the Regulatory representative on cross-functional teams supporting products throughout the stages of development and commercialization.
·
Perform regulatory assessment on all proposed change control; gather required data as needed to defend a Regulatory filing strategy; coordinate and prepare post-approval supplements if warranted.
·
Manage, prepare, publish using eCTD software well-organized, scientifically sound CMC and safety-related regulatory submissions which include ANDAs, Amendments, Annual reports, PSUR and Supplements that comply with applicable regulatory requirements in eCTD format.
·
Coordinate and communicate timelines and deliverables with Regulatory Operations, Labeling and other key departments to facilitate quality CMC and safety-related regulatory submissions, including ANDAs, Amendments, Annual reports, PSUR and post approval Supplements.
·
Review technical reports, summary documents and change controls (chemistry, manufacturing and analytical controls) for appropriate content and justifications as well as for adherence to regulatory guidelines, strategies, and commitments.
·
Work with partners to create product labeling compliant with FDA, and compendial requirements for drug products.
·
Contact FDA and other Regulatory authorities for review status updates for pending applications and supplements.
Education required:
·
Bachelor's degree required in a scientific disciple such as Chemistry, Biology, Pharmacy or other health related field. Graduate degree preferred.
Experience:
·
Minimum 5 years of experience in the Pharmaceutical Industry.
·
Knowledge/Skills/Qualifications:
·
Hands on experience in leading a variety of Regulatory submission activities (ANDAs, Post Approval Supplements, PSURs, Annual Reports.)
·
Familiar with a variety of pharmaceutical concepts, practices and procedures and the functioning of a regulatory affairs department.
·
Ability to interpret Regulatory Authority policies and CMC guidance and correctly apply them as appropriate throughout the product life-cycle.
·
Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.
·
Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.
·
Familiarity with Trackwise
·
Ability to manage a variety of assignments.
·
Detail oriented and highly organized.
·
Strong interpersonal skills and ability to deal effectively with a variety of personnel including senior management
Additional Information
Thanks and Regards
Dishant Nagar
************
Design and Analysis Engineer 3
Lancesoft job in Berkeley, MO
This job is with Encode, Inc a fully owned subsidiary of Lancesoft ·Assists with the development and documentation of electronic and electrical system requirements. ·Develops or modifies basic hardware and software designs based on defined requirements.
·Performs system tests to verify operational and functional requirements.
·Supports fabrication technicians and suppliers'questions during build and fabrication process
·Supports resolution of product integration issues and production anomalies.
·Supports hands-on troubleshooting of test racks
·Perform acceptance test procedures to demonstrate conformance to design and document results
·Develop and maintain scripts used to run test functions using C and C++
·Researches basic technologies for potential application to company business needs
This position requires the ability to obtain a US Security Clearance for which the US Government requires US Citizenship as a condition of employment.
Basic Qualifications (Required Skills/Experience):
·Bachelor of Science degree from an accredited course of study in engineering, engineering technology (includes manufacturing engineering technology), chemistry, physics, mathematics, data science, or computer science.
·Education or work-related experience with a Bachelors (level 1)
·5+ years of work-related experience with a Bachelors OR 3 yrs work-related experience with a Masters
Preferred Qualifications (Desired Skills/Experience):
·Strong problem-solving and debugging skills
·Experience with laboratory test equipment (oscilloscopes, logic analyzers, etc.)
·Excellent written and verbal communication skills
·Strong foundation in C, C++, and python
·Siemens Capital experience
Bachelor's degree and typically 5 or more years'experience in an engineering classification or a Master's degree with typically 3 or more years'experience in an engineering classification or a PhD degree with experience in an engineering classification. Bachelor, Master or Doctorate of Science degree from an accredited course of study, in engineering, computer science, mathematics, physics or chemistry. ABET is the preferred, although not required, accreditation standard.
Product Security Engineering 2
Lancesoft job in Saint Charles, MO
This job is with Encode, Inc a fully owned subsidiary of Lancesoft Active Top Secret Clearance Primary Responsibilities: Team members will work with other industry partners in the development and execution of a comprehensive assessment program supporting the specialized Advanced Weapons Proprietary Programs in the Space, Intelligence & Weapons Systems (SIWS) organization. These individuals will act as the primary product security engineers on the program for assessing, updating, and maintaining the security posture of the programs. This team will be supporting the program's systems by interacting continuously with the cyber team compliance team to remediate any vulnerabilities found during automated or manual cyber scans. A detailed oriented individual with a strong leadership skillset is a must for this position.
•Assess organization-wide security and privacy risk and update assessment results on an ongoing basis
•Perform system analysis and develop system test for cyber threats, cyber test activities, and the cybersecurity of large-scale events
•Ensure product security engineering development lifecycle is followed, with an emphasis on clear requirements development/verification (using CAMEO)
•Perform criticality analysis to include the ability to work with suppliers, identify critical components, and integrating them into the overall system
•Perform cyber risk assessments and develop risk mitigation plans (i.E., POA&Ms, SCRM, etc.) using a variety of tools including but not limited to CAMEO
•Support and facilitate various ATO/IATT packages including processing IAVMs and CTOs for the same
•Perform software assurance tasks, including but not limited to software assurance risk reports
•Support proposal development efforts, including but not limited to: BOE generation, GR&A development, trade study analysis
•Support the engineering installation & analysis of patches and various system updates and upgrades to determine system consequence of these changes
•Attend, collect data from, out brief, and facilitate collaboration and project management from various program boards
•Applying Security Technical Implementation Guides (STIGs)
•Managing and addressing any Cyber Tasking Orders (CTOs) related to the Cyber Tools
•Documentation and verification of all installation and configuration steps for the labs and operations deliveries
•Providing feedback to Cyber Leadership and engineers to improve the cybersecurity tools and processes
•Collaborating with local Information System Security Officers (ISSOs) to ensure compliance with relevant cybersecurity standards and regulations
•Support cyber threat intelligence activities
•Support the development and maintenance of cyber scanning, patching, remediation, tools and applications
•Support, as required, TEMPEST, DFARS, COMSEC, CNSSI, and other compliance drivers as needed
•Perform and/or support the development of tools for cyber forensics
•Develop, define efficiencies and improvements to tools to improve team productivity
•Perform system analysis trade studies to define technical concepts and solutions
This position requires an active Top Secret U.S. Security Clearance. (A U.S. Security Clearance that has been active in the past 24 months is considered active.)
Basic Qualifications (Required Skills/Experience):
•Bachelor of Science degree from an accredited course of study in engineering, engineering technology (includes manufacturing engineering technology), chemistry, physics, mathematics, data science, or computer science.
•Current DoD 8570 certification at IAT Level II / IAM Level I or higher (e.G., Security+, GSEC, SCNP, SSCP, CISSP, CISA, GSE, SCNA)
•1+ years of experience in product security / cybersecurity engineering
•1+ years of experience with industry standard cybersecurity frameworks (NIST, OWASP, DFARS)
•Experience using analytical, collaboration, communication and organizational skills
Preferred Qualifications (Desired Skills/Experience):
•Experience using CAMEO (proficiency preferred)
•2+ years of experience in Windows/RHEL System admin experience, installing, tuning & troubleshooting Cyber Tools to include ESS/HBSS, ConfigOS, Splunk, etc.
•2+ years of experience in configuring, running, and scripting audit tools
•2+ years of experience using knowledge of Software Assurance (SwA) static and/or dynamic code analysis (e.G. Fortify)
•Experience with Federal Information Security Management Act (FISMA)/RMF and National institute of Standards and Technology (NIST) 800-53 requirements
•Experience leading system and component level cyber test and evaluation, including threat and security assessments, and tabletop exercises
•Experienced self-starter with strong written and oral communication skills, and a focus on translating technically complex issues into simple, easy to understand concept
•Growing understanding of DoD defense systems architectures and communications system concepts, mission, and common system test and data analysis techniques
Typical Education/Experience:
Associate (2): Education/experience typically acquired through advanced technical education from an accredited course of study in engineering, engineering technology (includes manufacturing engineering technology), computer science, engineering data science, mathematics, physics or chemistry (e.G. Bachelor) and typically 2 or more years'related work experience or an equivalent combination of technical education and experience or non-US equivalent qualifications. In the USA, ABET accreditation is the preferred, although not required, accreditation standard.
Education/experience typically acquired through advanced technical education from an accredited course of study in engineering, engineering technology (includes manufacturing engineering technology), computer science, engineering data science, mathematics, physics or chemistry (e.G. Bachelor) and typically 2 or more years'related work experience or an equivalent combination of technical education and experience or non-US equivalent qualifications. In the USA, ABET accreditation is the preferred, although not required, accreditation standard.
Travel Nurse RN - ED - Emergency Department - $2,148 per week
Lancesoft job in Belleville, IL
LanceSoft is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Belleville, Illinois.
Job Description & Requirements
Specialty: ED - Emergency Department
Discipline: RN
Duration: 13 weeks
36 hours per week
Shift: 12 hours, nights
Employment Type: Travel
Years of experience REQ: 2 years required
First-timers accepted: Y
Weekend REQ: Every other
Certs REQ: ACLS, BCLS, PALS, NIH required. CPI, TNCC preferred.
About LanceSoft
Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization. Lancesoft Inc. is one of the highest rated companies in the industry. We have been recognized as one of the Largest Staffing firms and ranked in the top 50 fastest Growing Healthcare Staffing firms in 2022. Lancesoft offers short- and long-term contracts, permanent placements, and travel opportunities to credentialed and experienced professionals throughout the United States. We pride ourselves on having industry leading benefits. We understand the importance of partnering with an expert who values your needs, which is why we're 100% committed to finding you an assignment that best matches your career and lifestyle goals. Our team of experienced career specialists takes the time to understand your needs and match you with the right job Lancesoft has been chosen by Staffing Industry Analysts as one of the Best Staffing Firms to Work for.LanceSoft specializes in providing Registered Nurses, Nurse Practitioners, LPNs/LVNs, Social Workers, Medical Assistants, and Certified Nursing Assistants to work in Acute Care Centers, Skilled Nursing Facilities, Long-Term Care centers, Rehab Facilities, Behavioral Health Centers, Drug & Alcohol Facilities, Home Health & Community Health, Urgent Care Clinics, and many other provider-based facilities.
Benefits
Weekly pay
Medical benefits
Asset Administration Specialist
Saint Louis, MO job
BCforward began as an IT business solutions and staffing firm. Founded in 1998, BCforward has grown with our customers' needs into a full service personnel solutions organization. BCforward's headquarters are in Indianapolis, Indiana and also operates delivery centers in 20 locations in North America as well as India and Puerto Rico. We are currently the largest consulting firm and largest MBE certified firm headquartered in Indiana.
Job Title: Asset Administration Specialist
Job Location: SAINT LOUIS MO 63101
Job Duration: 6+ Months
Rate: $22.22/Hr
Job Description:
Manage asset inventory daily
Perform quarterly asset lease roll and return process for assets with expiring leases. Perform annual asset inventory validation
Research and locate missing AIC owned assets
Procure and track new assets
Coordinate account management / access credentials
Coordinate, manage and track shipment of assets and returns (e.g., laptops, photo badges, etc.)
Additional Information
Namratha Gandavarapu
************
Project Engineer 4
Lancesoft job in Hazelwood, MO
This job is with Encode, Inc a fully owned subsidiary of Lancesoft Provides the Engineering leadership to a team representing multiple skill areas, which may include internal and external resources and customers. Develops statement of work (SOW) to satisfy research and development, ongoing and new business requirements. Works with customers and management to obtain approval. Responds to changes to SOW, assesses the impact and negotiates proposed changes to determine modifications to the deliverables, resources, costs and schedules. Leads project execution to complete the work statement. Identifies performance metrics. Plans, identifies, and coordinates resources required over the life of the project or program. Defines plans for risk mitigation and opportunity. Compares actual results to baseline plan to assess project performance, efficiencies, productivity and lessons learned. Provides technical, business and integration leadership for the development and execution of project or team plans. Works under minimal direction.
·The Government Training Engineering (GTE) team is seeking a highly motivated Project Engineer to serve in the role of USN Air Dominance Principal Engineer, located in Berkeley, Missouri. The selected candidate will join the Office of the Chief Engineer (OCE) and will be responsible for leading engineering proposal activities in support of new business opportunities for the F/A-18, MQ-25, or T-45 platform. Further, the role will lead planning and execution of training device projects as they relate to the USN training.
·The USN Air Dominance OCE is responsible for the proposal, development, integration, delivery, and sustainment of a wide range of world-class training solutions to train the next generation of pilots. Your role includes project management, technical leadership and a strong desire to get the job done. You will be collaborating with the engineering teams and program management to maintain a common vision and deliver winning products.
·The USN product portfolio is an exciting, dynamic program that is dedicated to breaking the norm. Join the team and Let's Go Fly!
·Required Qualifications:
·Bachelor of Science degree from an accredited course of study in engineering, engineering technology (includes manufacturing engineering technology), chemistry, physics, mathematics, data science, or computer science
·3+ years of experience leading teams in a formal and/or informal role
·5+ years of experience with project management in an engineering environment
·Experience developing technical proposal responses and estimates
·Experience developing and tracking program plans/schedules and budgets for technical projects
·Preferred Qualifications:
·5+ years of experience leading teams in a formal and/or informal role
·7+ years of experience in engineering project management
·Experience with Training Systems and/or military aircraft platforms
·Experience with acquisition processes (e.G. DoD Acquisition, Foreign Military Sales, Direct Commercial Sales)
·Experience with Internal Research and Development (IRAD) projects
·Cost account management and/or earned value management experience
·Experience working within a SAFe Agile team
EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.
Software Engineer-Simulation 3
Lancesoft job in Hazelwood, MO
This job is with Encode, Inc a fully owned subsidiary of Lancesoft Responsibilities •Designs, architects, and develops simulation models, simulation visualizations, virtual environments/platforms, and frameworks to enhance test performance, safety, and durability of software and hardware systems throughout the entire product lifecycle.
•Partners with stakeholders to review and identify simulation requirements and dynamics of the systems being simulated.
•Performs design, modeling, simulation, testing, and analysis to assess and optimize overall system performance and capabilities.
•Performs data collection and processing for use in simulations.
•Validates, verifies, and refines simulation software code, models, simulations, test procedures and test environments, executing test procedures and documenting test results and models against real-world data, test data, benchmarks, or other similar models.
•Documents and maintains technical code, algorithms, specifications and descriptions of simulation models.
•Partners with cross functional engineering teams to enable integration of simulation software with hardware devices and systems.
•Implements current and emerging technologies, tools, frameworks, and methods in the software engineering simulation environment.
•Modernizes, migrates, sustains, and updates simulation software to adapt legacy systems to new operating systems.
•Performs simulation software project management functions.
Basic Qualifications
•Bachelor's Degree in an engineering discipline
•10+ years of experience in software engineering
•5 years of experience in C++, C#, C, Rust or other programming languages
•5 years of experience in Window and/or Linux distributions
•5 years of experience in Gitlab or IDE tools
•5 years of experience in software development/ agile environment
Preferred Qualifications
•Knowledge of aircraft systems, including weapons, night vision system, mechanics, hydraulics, electronics, flight controls, etc.
•Knowledge of cloud architecture, including the different types of clouds (public, private, and hybrid), the different cloud platforms and the various components involved (computing, storaging and networking). Ability to automate and script skills. Knowledge of containerization technologies which includes understanding how to manage containers, deploy applications in a containerized environment, and troubleshoot issues. Knowledge of understanding of networking concepts, including IP addressing, subnetting, routing, and security (focus on security best practices and technologies).
•Knowledge of specification format requirements, guidelines, and change control processes. Understanding of relationship between specifications/standards and aircraft/product certification systems.
•Knowledge of various engineering disciplines such as electrical, mechanical, and systems. The ability to communicate with technical personnel from multiple skill areas and functions to evaluate technical information and issues impacting design, production, and support of products, services, or other deliverables.
•Knowledge of how to derive and allocate requirements (e.G., system, sub-system, software) and show traceability throughout the product lifecycle.
•Knowledge and ability to design, develop, integrate, apply, and test software models, simulations, framework environments, tools, and applications with higher order programming languages, assembly, and auto-code. Ability to perform Application Programming Interface (API) design, implementation, and testing. Knowledge of real-time software architecture and design methodologies to synthesize models and simulation frameworks that meet real-time requirements;this includes knowledge of real-time target environments, its processor and network architecture, communication protocols, and electrical interfaces.
•Knowledge of software architecture and design methodologies. Ability to synthesize software architectures and designs that meet requirements, characteristics and constraints.
•Knowledge of build and execution environments that include hosts, processors, operating systems, and networks. Ability to build, integrate, test, and troubleshoot software components comprising simulation models and build/execution frameworks. Knowledge of verification, validation, certification, and qualification processes.
•Ability to design and develop software testing processes for different units, modules or components of a software application as a combined and integrated entity. It includes deep knowledge of integration-testing tools.
•Ability to apply knowledge of 2D and/or 3D computer graphics to generate data representation and to communicate information. Ability to build animated graphics--graphic simulations simulating how systems work. Understanding of visual analytics tools and research. Background and familiarity with algorithms for image processing. Knowledge of multiple programming languages and operating systems to develop prototypes in this technology area. Ability to integrate hardware and software components into demonstrations.
Bachelor's Degree in an engineering discipline
Travel Nurse RN - Med Surg - $2,290 per week
Lancesoft job in Alton, IL
LanceSoft is seeking a travel nurse RN Med Surg for a travel nursing job in Alton, Illinois.
Job Description & Requirements
Specialty: Med Surg
Discipline: RN
Duration: 13 weeks
36 hours per week
Shift: 12 hours, nights
Employment Type: Travel
Years of experience REQ: 1
First-timers accepted: Y
Weekend REQ: Every other
Certs REQ: ACLS, BCLS, NIH
About LanceSoft
Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization. Lancesoft Inc. is one of the highest rated companies in the industry. We have been recognized as one of the Largest Staffing firms and ranked in the top 50 fastest Growing Healthcare Staffing firms in 2022. Lancesoft offers short- and long-term contracts, permanent placements, and travel opportunities to credentialed and experienced professionals throughout the United States. We pride ourselves on having industry leading benefits. We understand the importance of partnering with an expert who values your needs, which is why we're 100% committed to finding you an assignment that best matches your career and lifestyle goals. Our team of experienced career specialists takes the time to understand your needs and match you with the right job Lancesoft has been chosen by Staffing Industry Analysts as one of the Best Staffing Firms to Work for.LanceSoft specializes in providing Registered Nurses, Nurse Practitioners, LPNs/LVNs, Social Workers, Medical Assistants, and Certified Nursing Assistants to work in Acute Care Centers, Skilled Nursing Facilities, Long-Term Care centers, Rehab Facilities, Behavioral Health Centers, Drug & Alcohol Facilities, Home Health & Community Health, Urgent Care Clinics, and many other provider-based facilities.
Benefits
Weekly pay
Medical benefits
MP&P Engineer 4 Skill Code:6B2-Electrical PM&P
Lancesoft job in Berkeley, MO
This job is with Encode, Inc a fully owned subsidiary of Lancesoft Applies engineering knowledge of electrical, electronic, and electro-mechanical components in evaluation of components for assembly and subassembly repair/design Directly supports Sub-contractors and Suppliers to ensure their electronic components are qualified for client usage per the contract and the Parts Management Plan
Significant experience with a harsh environment/high reliability design environment, including previous aerospace, medical device, automotive, or industrial design/application experience.
Experience with connectors, wires, and cables, including the fabrication of cables/bundles, installation of cables/harnesses, etc.
Qualifications
Education/experience typically acquired through advanced technical education from an accredited
course of study in engineering, computer science, mathematics, physics or chemistry (e.G.
Bachelor) and typically 9 or more years'related work experience or an equivalent combination of technical education and experience(e.G. PhD+4 years'related work experience, Master+7 years'related work experience). In the USA, ABET accreditation is the preferred, although not required, accreditation standard.
Must Have:
Electrical design and/or Test experience with electrical components, wiring harnesses, connectors and cables.
Specific experience in any military aerospace discipline, either as a defense contractor or as former military, especially in the area of Electrical Wiring Interconnection Systems (EWIS)
Specific experience with military electronics. Not necessarily aerospace, as long as its directly related to one of our electrical disciplines (i.E. Components, wire/cables, processes, etc.)
Specific and extensive experience with the electrical mil specs and aerospace industry specs that are relevant to our day to day.
Deep experience/insight with wiring design, cables, connectors, etc. Someone who worked in a position where this was a key element of their primary responsibilities for 5+ years.
Understanding of Aircraft and Weapons design/requirements to recommend the correct Alternate electrical components for new product development and legacy programs
Nice to Have:
Uses Project Management tools to meet cost, schedule, and technical performance.
Incorporates Environmental Health and Safety (EHS), LEAN and Quality principles into (1) materials and processes, (2) research and qualification, (3) work procedures and (4) lab testing and qualification
Supports, establishes work statements, defines strategies, and/or provides consultation with peers while keeping management informed
Significant experience with military and/or industry specifications.
Education/experience typically acquired through advanced technical education from an accredited course of study in engineering, computer science, mathematics, physics or chemistry (e.G. Bachelor) and typically 9 or more years'related work experience or an equivalent combination of technical education and experience (e.G. PhD+4 years'related work experience, Master+7 years'related work experience). In the USA, ABET accreditation is the preferred, although not required, accreditation standard.