job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases, our partner strives to develop critical therapies for the small population - mostly children - that suffer from near unheard of conditions. If you're looking for an exciting opportunity to make a difference with an established company, this is the position for you! location: Novato, California job type: Contract salary: $29.21 - 34.36 per hour work hours: 9 to 5 education: Bachelors responsibilities: Duties:
- Support Quality Compliance processes including inspection readiness, self-inspection program, data integrity initiatives, and regulatory certification activities
- Support or lead continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).
- Adhere and follow cGMPs guidelines and procedures. Escalate non-compliance concerns to management.
- Interface with other BioMarin departments (Manufacturing, Quality Control, Technical Development, Quality Assurance, etc.) and contractors as necessary
- Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives
- Other duties as assigned
qualifications: Skills:
- Prior experience in Manufacturing, Quality Control, and Quality Management System (QMS) processes
- Excellent written, verbal, analytical, and interpersonal skills
Required
- MANUFACTURING PROCESSES
- QUALITY MANAGER
- MANUFACTURING PROCESS
Education:
- BS/BA in a scientific discipline or related field and 4-6 years in a biologics manufacturing environment
skills: Quality Assurance, ICH Regulations, 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 ...@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.