job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find 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. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you! location: Novato, California job type: Contract salary: $36.79 - 43.29 per hour work hours: 9 to 5 education: Bachelors responsibilities: Summary: We are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high-level of initiative, energy, and motivation are key role requirements, as well as organizational skills and the ability to motivate others. The Quality Associate 1 reports to the Quality Manager and is responsible for supporting Quality Systems related to operations, product specification change controls and batch release processes. This position requires interaction with multiple levels in Quality, Regulatory Affairs, Manufacturing, Supply Chain, Materials Management, and Contract Manufacturing Operations. Job Responsibilities Create and/or revise product specification documents, following MAA, BLA, CTA, IND and/or IMPD filings, in BioMarin's controlled document management system (Veeva).Initiate and set-up change control workflows for product specification revisions in Veeva and BioMarin's quality management system.Coordinate Veeva change control workflows for review and approval of product specification revisions.Monitor and ensure document implementation timelines.Monitor backlog in associated trackers.Generate custom Certificates of Analysis to support lot release, new market applications, annual product reviews, and/or market renewals.Ensure all individual training and group-specific guidelines are kept current.Provide assistance with training new staff. qualifications: Experience: Minimum 3-5 years of experience in a Quality, Compliance, and/or Regulatory setting.Strong attention to detail, organization and communication skills.Ability to maintain organization of a large volume of data in a systematic mannerProficiency with computer systems (Microsoft Office Suite).Proficiency with eQMS (Veeva), LIMS, Oracle EBS, eCDMS (Veeva) and Office365 preferred. Required REGULATORY DOCUMENT REVIEW Education: Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical engineering, chemical or biological sciences) is required.Advanced degree preferred. skills: Quality control, SOP, Regulatory Briefing Documents, Laboratory Information Management Systems (LIMS) 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). Applications accepted on ongoing basis until filled. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. 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.