Quality Assurance Supervisor - Irvine, CA
100% onsite
1 st shift (M-F) 8am-4pm
Base Salary: Up to 93K
Bonus: 5-10%
No Relocation
location: Irvine, California
job type: Permanent
salary: $85,000 - 93,000 per year
work hours: 8 to 4
education: Bachelors
responsibilities:
- Assist in supervision of various quality programs such as but limited to labeling, GMP training, compliance, document control, information tracking, and equipment calibration.
- Manages or assists in the compliance profile of the site and drives continuous improvements, QRB and metrics.
- Review and approve protocol/reports for various qualifications and validations.
- Serve as a backup to Senior Quality Manager in their absence.
- Uses statistical process control to evaluate trends. Provide periodic KPI trend reports to senior management as required.
- Review and approve Manufacturing, Packaging, and Quality Operation Processes, and GMP documentation.
- Approve Master Labels and Finished Product C of A's. Assist with creation, revision and approval of SOP's. Review and approve change controls.
- Improves and/or develops comprehensive quality sub-systems (e.g., corrective/preventative action, MRB, customer complaints, vendor management programs, etc.).
- Assist Senior Management during inspections by FDA, DEA, and other regulatory agencies and customers.
- Helps in establishing raw material and finished product specifications based on regulatory requirements and customer needs.
- Lead investigation activities, perform root-cause analyses, and develop corrective and preventative action plans.
- Assist in preparations for Annual Product Review.
- Comply with cGMP regulations and follow all standard operating procedures.
- Other related duties as required.
qualifications:
- Bachelor's Degree, preferable in a scientific discipline.
- 5+ years of experience in Quality Assurance in a GMP facility, including people management and/or equivalent combination of education and experience.
- Strong commitment to quality standards with leadership and management skills.
- Ability to read and interpret technical procedures, SOP's, GMP's and governmental regulations: 21 CFR 111, 11, 210, and 211.
- Strong communication skills, both written and verbal.
- Possess positive qualities of effective leadership, staff motivation and conflict resolution.
- ASQC quality certifications, ISO 9000 or other Audit training preferred.
- Strong knowledge of validation, investigations, application of audit principles, concepts and practices related to a regulated quality system is required.
- Strong solid dose manufacturing quality compliance experience is preferred.
skills: Chemistry, 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 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.
