Seeking a Quality Specialist to support Company's digital quality transformation by leading validation testing, driving change management, and managing cross-functional projects across our digital Quality platforms. This role ensures that enhancements to our digital quality systems - encompassing electronic batch release, quality workflows, and GxP data solutions - are compliant, reliable, and successfully adopted by global users.
location: Telecommute
job type: Contract
salary: $35.00 - 39.84 per hour
work hours: 9 to 5
education: High School
responsibilities:
- Lead validation activities for digital quality system updates, including test planning, execution, documentation, and issue resolution.
- Drive change management to support new system capabilities, user adoption, communications, and training.
- Manage multiple digital quality projects involving system enhancements, process improvements, and cross-functional coordination.
- Ensure digital workflows and integrations supporting material and product release meet GxP requirements.
- Collaborate with internal partners and external vendors to ensure timely, compliant, and high-quality delivery.
qualifications:
Required:
- Strong GxP background with direct experience in material and product release.
- Hands-on experience with digital quality systems (e.g., eQMS, complaint systems, digital batch release, quality data integrations).
- Proven capabilities in validation testing, change management, and project leadership.
- Excellent communication skills (English & Spanish preferred) and ability to work effectively in a matrixed, cross-functional environment.
- Exceptional attention to detail, analytical mindset, and ability to manage competing priorities.
- 5+ years of biopharmaceutical experience in Quality, Validation, Manufacturing, Regulatory, or related areas.
- Knowledge of GMP regulations, digital quality systems, and modern quality technologies.
skills: Project Management, Good Laboratory Practices (GLP), Good Clinical Practice (GCP), Good Manufacturing Practices (GMP), Change Control Management, Quality Assurance (QA), Quality Management Systems (QMS)
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 with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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.
