Great opportunity QA Specialist
Onsite / 1 st Shift (M-F) 8am-5pm
location: Irvine, California
job type: Permanent
salary: $47,000 - 60,000 per year
work hours: 8 to 4
- Comply with cGMP regulations and all standard operating procedures.
- Assist in ensuring all personnel comply with cGMP regulations and follow all standard operating procedures. Provide cGMP guidance as needed.
- Coordinate and organize internal training program to ensure personnel performing GMP activities are trained per internal SOP.
- Perform timely review of GMP records (Batch Records, Laboratory Records, Notebooks, etc). Work closely with QA management to proactively address the quality of documentation. Review and release components, raw materials, and finished products.
- Create, revise and/or review SOPs, protocols, reports, change controls and other GMP documentation.
- Conduct and/or review complaint, non-conformance, and deviation investigations.
- Support and organize stability studies for finished product.
- Provide assist in preparation and during internal, customer and agency audits.
- Maintain assigned Quality Systems or processes as assigned. Perform tracking and presenting of quality metrics (KPIs). Work with QA management on continuous improvement of the Quality Systems to ensure compliance with regulatory guidelines.
- Use of electronic QMS and other software as required.
- Other related duties as assigned.
- Bachelor's degree in a scientific discipline or equivalent (4 years' experience) in a quality control or quality assurance function associated with manufacturing.
- 2+ years' experience in quality control or quality assurance function associated with manufacturing preferred.
- Experience and knowledgeable of cGMP regulations (21 CFR 210/211) preferred.
skills: Quality Assurance
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.
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.
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.