Immediate opening for a QA Frontline Associate (Night Shift) to support the Technical Operations team at a leading, global pharmaceutical company specializing in rare diseases.
The Technical Operations group is responsible for creating drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
The QA Frontline team is committed to providing real time QA support to the manufacturing facilities by performing on the floor batch record review and responding to quality-related events.
Schedule/Shift: 3rd shift, Sun.-Tues. and alt. Sat., 6pm-7am
location: Novato, California
job type: Contract
salary: $34.23 - 40.27 per hour
work hours: 9 to 5
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 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 day 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:
- B.S. in scientific discipline or equivalent work experience
- 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
KEY SKILLS:
- Quality Assurance (QA)
- Manufacturing
- Batch Record Review
- Documentation
- Change Control
- cGMP
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.
