Jobs.You will note from all these jobs and vacancies that the greatest emphasis is put on experience, and often hands on experience. Scholastic qualification is brushed over very quickly. Very often making it obvious that while a degree is handy, it is not essential. Statements to the effect that any similar degree will do, opens the door for all applicants with part of degree qualifications. Which then opens the door to all sorts of part time learning colleges, and correspondence studies. There is no other career structure that will pay similar money without much higher degree qualifications. These are live requirements copied over from our jobs bulletin board. Validation Specialists and Senior Validation Specialists with the right expertise and knowledge will be well rewarded by working with VTS Consultants, Inc. on many of our local projects in Massachusetts and surrounding states. This is a jobs opportunity for you to expand your knowledge and mechanical abilities working with the some of industries best validation engineers. As a VTS Consultant your responsibilities will include: 1. Writing of Commissioning, Qualification and Validation Protocols (Installation Qualification, Operational Qualification, Performance Qualification, Process Validation & Cleaning Validation) for Manufacturing Equipment, Laboratory Equipment and Aseptic Manufacturing Processes. 2. Coordination and execution of various commissioning and qualification tests. 3. Set up and operation of Validator 2000 equipment for thermal analysis of autoclaves, depyrogenation ovens, incubators and other controlled storage units. 4. Statistical analysis and interpretation of data obtained during testing phases. 5. Writing of Test Summaries and jobsFinal Reports. General Knowledge:
Job Requirements- Qualified candidates should possess a Bachelor's degree or equivalent experience in a scientific discipline, jobs preferably in the life sciences, engineering, or computer science fields jobs. A minimum of 2-5 years experience in commissioning and qualification within the Pharmaceutical, Biotechnology or Medical Device industry is necessary. Willingness to travel and successfully interface with subordinates, strong interpersonal and high level organizational skills required.
Please send resume to: HRDept@vtsconsultants.com or fax to: 413-253-0811 Note the similarity, great detail about experience. Academic qualifications barely mentioned. This one appears to try an all in one, advert for all jobs and classes of experienced people. Multiple jobs opportunities listed, please include position numbers or titles you are interested in the email subject. Multiple positions are in multiple geographical areas (AZ, CA, CT, DE, FL, IL, IN, MA, MD, MN, NC, NJ, NY, OH, PA, PR, RI, WA). Some state needs to be listed for Monster posting needs.
talent@xxxxxxxxxxxxxxtalent.com For all jobs listed there is need for Quality Assurance personnel too with similar skills. 1. Computer System Validation Specialist Computer Validation Specialists, Technical Writers, Documentation Specialists with 21 CFR Part 11 compliance experience. Assessment of several computer systems(Manufacturing, Laboratory, network, application software). Work with system owners to explain the assessment and remediation plans. Perform gap analysis for Part 11 compliance. Perform Risk Assessments, create compliance deliverables. Knowledge of FDA cGMP and related regulations and guidelines, specific knowledge of computer validation methodologies and principles. Jobs Experience in one or more of these jobs applications: 2. Laboratory Equipment Validation: We have an excellent career opportunity for a Validation Specialist in Laboratory Equipment Validation Services addressing 21 CFR 11. Develop strategic approach and detailed plan for the remediation of all technical operations for non-chromatographic laboratory equipment. Should have experience with laboratory equipment and processes, 21 CFR 11, demonstrated large scale project management skills and excellent written and communication skills. Communication with management, clients, project team members and consultants. Ensure projects are completed on time and within budget. Provide schedule/time/resource input for proposals. Oversee compliance with quality standards. 3. Validation Consultants: To do risk assessments and audits, GAP analysis, validation strategy development and planning, develop SOPs, protocols and reports, medical device (QSR), 21CFR Part 11. Provide regulatory guidance regarding CSV or Process and Equipment Validation procedures and cGMP, cGLP or cGCP. Generate system specifications, validation documents and CSV procedures. Perform on-site jobs assessments, audits, risk analyses and client interviews. BS/BA degree in engineering, biochemistry or related field work experience in the pharmaceutical industry and QA area. Knowledge of Computer System Development Life Cycle (SDLC) requirements and FDA regulations, GxPs, and experience with validation of automated processes and equipment.
5. LIMS Validation: Responsible for writing OQ and PQ test scripts for new functionality and modifying existing test scripts. Responsible for managing documents in the corporate document management system. In addition you will also be responsible for running test scripts, documenting errors and suggesting corrective actions. - Experience withh lab management proceses, applications, and databases (SQL*LIMS, Labware, Watson, LabManager, Sample Manager, Nugenesis, Empower, other LIMS applications) validation Test Script writing. 6. SAP Validation Consultants: Multiple person jobs requirement for ERP / SAP Validation Consultants. Functional consultants with testing background are also acceptable. Strong experience with writing and executing validation plans, generating and executing test scripts and protocols, conducting testing, and preparing final summary reports. SOP writing experience preferred. 7. SAP Functional Consultants Description:
8. EDMS Validation Consultant Candidates must have specific hands-on computer validation experience with any EDMS package. Hands-on SDLC jobs methodology experience in Computer Validation in FDA related industry. Demonstrated experience is required in writing, reviewing and executing computer validation documentation and performing software testing and computer validation on EDMS applications and systems. Candidate must have working knowledge of 21 CFR Part 11 and cGMP regulations. 9. Software Application Testers To be considered for this role, you must have jobs experience with the following: Strong manual data tester who can create test plans, test cases and an overall testing strategy and then create/execute reusable test scripts for Web applications. The appropriate candidate will have experience with reporting and tracking defects as well as create systems of metrics to validate movement into production. The ideal candidate will be responsible for all areas of testing outside of the black box, and be familiar with data set-up. This is a hands on planning and execution role that requires a person be very detail oriented, self motivated, and organized to manage multiple projects. Should be able to read SQL statements and understand how to create negative test and integration testing . Should understand Configuration/Release management as it relates to the development lifecycle. All positions require the following skills:
KEYWORDS: Quality, Quality Assurance, Quality Control, Remediation, Document Control, Validation, Investigations, Pharmaceuticals, Biotech, Manufacturing, Contracting.
10. Sales Professional- Account Manager Sales Professional to service this geographical Region. This is a spectacular opportunity for an entrepreneurial person to rule a region as an individual contributor. We can offer you the opportunity to grow your career with a consulting company in the regulatory compliance industry and become a highly visible member of the sales team. We offer Base + High Commission structure with no cap.
3+ years front line sales in life sciences sector (pharma, biotech, med device). Experience selling consulting services. Seeking candidates with experience selling large scale multi-year contracts. Ability to work independently, from a home office. Results oriented. Ability to apply creativity to overcome obstacles.
If interested please reply with an updated resume in a MSWord format to: |