- Act as Quality Assurance (QA) contact for Change Control(s) for Computerized System activities
location: Telecommute
job type: Contract
salary: $55.00 - 61.96 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Review and Approve validation deliverables (e.g. Validation Plan, Requirement Assessment, support Testing Protocols, Summary Reports, etc.)
- Change Agent and advocate for the Risk Based Validation program
- Able to act as SME for multiple Quality processes (e.g. Deviations, CAPA)
- Review and Approve SOPs and associated documents
- Review/Approve Periodic Reviews for GxP Systems
- May perform software Supplier Evaluations as needed
- Support project initiatives, process improvements and or projects
- May be required to present on topics or issues to management
- May support audit & Inspections requests as needed
- May support other duties as required
qualifications:
- Masters degree in technical or related subject and 3 years with directly experience
- Bachelors degree in technical or related subject and 5 years with directly experience
- Will consider those that have significant years of direct experience in lieu of education requirements
- 5+ years experience in a regulated industries in a similar role (e.g. Biotechnology, Medical Device, Aerospace)
- Demonstrated strong Knowledge of industry and business principles
- Demonstrated strong problem-solving abilities and strong risk assessment capabilities
- Validation and Change Control experience (Highly preferred: Risk Based Validation experience and or strong Computer System Assurance (CSA) knowledge)
- Strong organizational skills, including ability to follow assignments through completion.
- Initiate and lead cross functional teams as needed
- Collaborate and communicate with higher level outside resources.
- Strong communication (both written and oral), facilitation, and presentation skills.
- Strong skill in working independently and to effectively interact with various levels of management
- Ability to lead and influence staff outside QA organization
- Able to manage performance issues and conflict
- Ability to evaluate documentation/ operations according to company and regulatory guidelines
- Ability to interpret and apply GMP, GLP, GCP, GPvP regulations
skills: Good Laboratory Practices (GLP), Good Clinical Practice (GCP), Good Manufacturing Practices (GMP), Quality Assurance (QA)
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, 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 offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
