A Operation Specialist is needed for a manufacturing company considered one of the world's leading innovators in materials science in the Woodland, CA area. This job is responsible for maintaining and executing quality systems, documentation, and compliance activities within a regulated biotechnology or pharmaceutical environment, ensuring adherence to ISO 13485 and FDA 21 CFR 820 standards.
location: Woodland, California
job type: Contract
salary: $17.25 - 27.21 per hour
work hours: 8am to 4pm
education: Associates
responsibilities:
- Create, maintain, and execute Quality Systems in compliance with ISO 13485 and FDA 21 CFR 820.
- Compile, organize, and file quality-related documentation for easy access during regulatory and customer audits.
- Drive completion and routing of change control documents.
- Issue labels and batch record documentation for all products.
- Maintain and issue employee training records.
- Coordinate review and revision of procedures, specifications, and forms.
- Assist with writing or revising Master Manufacturing Records (MMRs) and Quality Operating Procedures (QOPs).
- Conduct initial review of completed batch records for adherence to Good Documentation Practices (GDP).
- Maintain accurate reporting and trending of: On-time Quality Control (QC) releases & Right-First-Time (RFT) batch record metrics
- Minimum: Associate degree with relevant experience.
- Preferred: Bachelor's degree in Biology or Chemistry.
Required Skills
- Ability to develop, update, and train on Standard Operating Procedures (SOPs).
- Working knowledge of ISO standards and Quality Management Systems (QMS).
- Familiarity with medical, pharmaceutical, or biotech environments (preferred).
- Experience in cell culture or microbiology labs (preferred).
- Experience with SAP and/or PeopleSoft (preferred).
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, etc.).
- strong organizational and time management skills.
- Excellent interpersonal and communication skills.
qualifications:
- Experience level: Experienced
- Education: Associates
skills:
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.
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.
