Quality Assurance (QA) Frontline Associate - 3rd shift, 4x10

Immediate opportunity for a Quality Assurance (QA) Frontline Associate working with a global biotechnology company located in Novato, CA

If you're looking for an exciting opportunity to make a difference with an established company, that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health, we invite you to apply today!

• Thurs-Sat and alternate Wed, 6pm-7am
• Sun-Tues and alternate Wed, 6pm-7am

education: Bachelors

responsibilities:

• Provide on-the-floor QA oversight and support to manufacturing operations
• Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations
• Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations
• Represent QA in support of deviations including active participation in Root Cause Analysis (RCA)
• Provide cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel
• Provide QA support including authoring, review, and approval of documents in Quality Management Systems in accordance with company policies
• Perform area walkthroughs
• Perform other duties and projects as assigned by management
• Please note that while this role primarily involves night and weekend shift hours, there may be occasions where the need for flexibility is required, as shift hours can vary depending on operational demands.

qualifications:

• Bachelor's degree (BS / BA) in a Scientific discipline or related field
• Three (3) - five (5) years' experience in a biologics manufacturing environment
• Prior batch record execution or review experience
• Prior experience in investigation, change control, other Quality Management Systems (QMS)
• Working knowledge of cGMPs
• Excellent written and verbal communication and interpersonal skills
• Must display strong analytical and problem-solving skills
• Manufacturing and Manufacturing Sciences experience preferred

• BATCH RECORD REVIEW
• QA
• ROOT CAUSE ANALYSIS
• PROBLEM-SOLVING
• CGMP

• TECHNICAL SERVICES
• CGMPS
• REAL-TIME
• CHANGE CONTROL
• QMS
• DOCUMENTATION
• BATCH RECORD
• MANUFACTURING OPERATIONS
• EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
• BATCH RECORDS

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.