|
|
|
|
Printer friendly  |
| Job Title: |
Validation, Quality Assurance Consultants - Multiple Openings, Nation wide |
|
Job Category:
|
Quality Affairs/Assurance |
|
Job description:
|
Multiple opportunities listed, please include position numbers or titles you are interested in.
Multiple positions are in multiple geographical areas (AZ, CA, CT, DE, FL, IL, IN, MA, MD, MN, NC, NJ, NY, PA, PR, RI, WA). Some state needs to be listed for Monster posting needs.
Experience level is 1 to 15 years as multiple positions.
For all positions 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 assesment and remediation plans. Perform gap analysis for Part 11 compliance. Perform Risk Assesments, create compliance deliverables.
Knowledge of FDA cGMP and related regulations and guidelines, specific knowledge of computer validation methodologies and principles. Experience in one or more of these applications:
EDMS (Documentum, QUMAS, Livelink)
ERP (JDE, SAP, Ross Systems)
Adverse Events (Argus, Oracle AERS, ARISg, Cerity)
IND Publishing (ISIToolbox, eCTDXPress, EZSubs, CoreDossier)
Laboratory Systems (Cyberlab, LabWare, Waters Millenium, Watson LIMS, SQL*LIMS, etc.)
Trackwise, Maximo, Clintrial, EZsub, Plateau.
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 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.
4. Process and Equipment Validation:
Provides Consulting Services within the FDA regulated industries nationwide. Must have experience in a pharmaceutical setting providing equipment qualification and process validation services. If you have experience with mixers, HVAC, WFI, Purified Water, Temperature Mapping, Autoclaves, Freeze Dryers, Cleaning Equipment or Plant Facilities Validation.
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 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:
Candidates with experience in any of the modules -- FI, SD, MM, HR, PM, PP, PS, QM.
At least 2 years of experiene in SAP Implementation.
Excellent verbal and written communication skills.
SAP certification will be an added advantage.
8. EDMS Validation Consultant
Candidates must have specific hands-on computer validation experience with any EDMS package. Hands-on SDLC 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
Candidate will work from Functional Specs, Requirements & Use Cases create test plans/strategy and test cases to perform manual testing of a web based application and web portal.
To be considered for this role, you must have 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:
Experience working in FDA regulated environment is preferred.
Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report).
Excellent communication skills.
Ability to work as a team player in a consulting environment.
With a willingness to travel, relocation is not necessary.
For direct and contract positions.
Must be willing to work extended hours (overtime is paid for).
Proficiency with MS Office tools
Documentation management
KEYWORDS: Quality, Quality Assurance, Quality Control, Remediation, Document Control, Validation, Investigations, Pharmaceuticals, Biotech, Manufacturing, Contracting.
|
|
Skills:
|
|
|
Employment type:
|
|
|
Salary Range:
|
Unspecified |
| |
| Other Information |
 |
|
| |
|
Degree:
|
Unspecified |
|
Experience (year):
|
Unspecified |
|
Job Location:
|
Nation wide - MD - USA |
|
Post Date:
|
11/19/2008 |
| |
| |
|
|
