We are seeking experienced Quality Assurance Managers with Computer Systems Validation (CSV) expertise to support GxP Computer Systems Quality Assurance team with one of our top clients located in Thousand Oaks, CA.
Schedule/Shift: These REMOTE roles require candidates to work standard PST or EST hours, with occasional flexibility for system releases.
Position Type: We have three (3) openings - Two 12-month contracts and One 6-month contract!
This is a high-impact opportunity for professionals with strong validation, change control, and compliance experience in regulated industries. You'll play a key role in ensuring system integrity, compliance with GMP / GLP / GCP guidelines, and driving process improvements.
location: Newbury Park, California
job type: Contract
salary: $50.00 - 61.96 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Act as Quality Assurance (QA) contact for Change Control(s) for Computerized System activities
- 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:
- 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.
- Validation and Change Control experience (Highly preferred: Risk Based Validation experience and or strong Computer System Assurance (CSA) knowledge)
Ability to evaluate documentation/ operations according to company and regulatory guidelines
Ability to interpret and apply GMP, GLP, GCP, GPvP regulations - 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: Quality Assurance, CAPA, GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GMP (Good Manufacturing Practice)
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 health, an incentive and recognition program, and 401K contribution (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.
