Seeking a QA Specialist with strong CSV / CSA expertise to provide quality oversight across computer system validation activities. This individual will play a key role in ensuring systems meet regulatory requirements and business needs. Candidates must demonstrate the ability to manage time effectively, evaluate complex problems, and deliver practical, risk-based solutions in a regulated environment.
Schedule/Shift:
- PART-TIME role, 20 hours per week
- Preferred working hours (PST), though EST is acceptable
- Flexible schedule; manager is open to different days and varying work hours
location: Newbury Park, California
job type: Contract
salary: $50.00 - 60.08 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Provide QA oversight for all computer system validation (CSV) activities.
- 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
qualifications:
- Doctorate degree (PhD) or Master's degree (MS) in technical or related subject and 3 years with directly experience OR
- Bachelor's degree (BS) in technical or related subject and 5 years with directly experience.
- Proven expertise in GxP-regulated environments with specific experience in CSV and/or CSA.
- Strong understanding of the SDLC and system lifecycle documentation.
- Experience with QA review of system validation and change control documentation.
- Project management skills
- Strong time management and organizational skills, with the ability to follow assignments through to completion.
- Demonstrated ability to lead or participate in cross-functional teams.
- Skilled at interacting with stakeholders at all levels, including regulatory agencies.
- Experience managing performance issues and resolving conflicts in a collaborative manner.
- Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development.
- Demonstrates alignment with company Values and Leadership Practices.
skills: Project Management, Quality Assurance, GCP (Good Clinical Practice), GMP (Good Manufacturing Practice), Process Engineering
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.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
