Things that will be RED FLAGS to the manager: No CSV (Computerized System Validation) or CSA (Computer Software Assurance) experience.
Top 3 Must Have Skill Sets:
- Prior knowledge in SAP validation preferred
- Hands on experience with all phases of Software Development Life Cycle (SDLC)
- Experience and knowledge with GxP and CSV/CSA requirements
- Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience.
- Previous experience leading teams, projects, programs or directing the allocation of resources.
- Prior knowledge in SAP validation preferred
- Project management skills
- strong organizational skills, including ability to follow assignments through to completion.
- Initiate and lead cross functional teams.
- Collaborate and communicate with higher level outside resources.
- Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development.
- strong communication (both written and oral), facilitation, and presentation skills.
- strong skill in working independently and to effectively interact with various levels.
- Able to manage performance issues and conflict
- Ability to evaluate documentation/ operations according to company and regulatory guidelines
- Ability to interact with regulatory agencies
location: TELECOMMUTE, Massachusetts
job type: Contract
salary: $42.00 - 52.50 per hour
work hours: 8am to 4pm
education: No Degree Required
responsibilities:
May perform or oversee the following functions:
- Review and approve Requirement Specifications, Design Specifications, Testing Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices
- Review and approve operational and administrative SOPs
- Review and approve Change Controls (QA Contact role for CCMS and ServiceNow changes)
- Review and approve Data Integrity Assessments
- Review and approve System Life Cycle Documents (i.e. test protocols) before use in production.
- Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information (e.g., Qualitative information, Quantitative research, Trend data)
- Anticipates and prevents potential problems
- Independently develops solutions that are thorough, practical and consistent with functional objectives
- QA oversight for the ERP Modernization S/4 project.
- Other minor SAP changes to support the business
qualifications:
- Experience level: Experienced
- Minimum 3 years of experience
- Education: No Degree Required
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.