As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global leader in biotechnology. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare and life sciences industries. This company is dedicated to discovering and developing innovative therapies that address serious diseases, with a focus on oncology, cardiology, and bone health. With a strong legacy of scientific excellence and a mission to improve patient outcomes worldwide, they offer a dynamic environment where your contributions will drive real change. If you're seeking a rewarding career that makes a difference, let us help you take the next step!
location: Newbury Park, California
job type: Contract
salary: $35.00 - 37.44 per hour
work hours: 8 to 4
education: High School
responsibilities:
- Support manufacturing by providing subject-matter expertise for drug substance upstream and downstream processes as process owner (PPO) or Single-use SME
- Lead sophisticated projects or parts of projects using project management skills.
- Resolve quick issues and execute function tests to troubleshoot and optimize process
- Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management.
- Own Quality Records, such as CCMS, CAPA, and CAPA-EV.
- Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations.
- Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.
- Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.
- Demonstrate strategic problem-solving skills and champion continual improvement.
- Ability to be on-site (flexible worker)
- As Process owner:
- Support operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills
- Develop/own drug substance manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs, Forms). Draft and develop user requirements for new technologies.
qualifications:
- High school/GED and 4 years work experience OR Associate's and 2 years work experience OR Bachelor's and 6 months work experience OR Master's
- Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
- Experience leading and managing projects and owning quality records.
- Proficiency in Smartsheets and Database/Quality Management Systems (CDOCS, Trackwise, Spotfire, etc.)
- Upstream / Downstream bioprocessing
- Quality record management (change controls, CAPA, etc.)
- Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule
skills: Quality Assurance, GMP (Good Manufacturing Practice), Manufacturing Operations
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.
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.
