The Planet Group
GxP Quality Assurance Senior Specialist
The Planet Group, San Francisco, California, United States, 94199
This range is provided by The Planet Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants. Base pay range $42.00/yr - $55.00/yr Direct message the job poster from The Planet Group Quality Assurance Senior Specialist – (Contract) – Hybrid - CA California Biotech seeks a Quality Assurance Senior Specialist for a hybrid contract opportunity near Fremont for a 6-month contract with possible extensions. The ideal candidate will have 3+ years’ hands-on QA experience working within Quality Systems in a GxP regulatory environment. This includes Utilities, Facilities, Equipment, Analytical Instruments and Computerized Systems. Additionally, this person must have experience in data integrity programs while interacting cross-functionally with QC, Manufacturing, Facilities, IT, Supply Chain and Regulatory Affairs.
Opportunity requires hybrid onsite meaning LOCAL CANDIDATES ONLY & NO RELOCATIONS FOR PROJECT. Responsibilities Performing various QA activities while ensuring compliance with organizational procedures and US/International regulatory requirements for drug products. Coordinating and tracking closure of quality records to include change controls, deviations, CAPAs, quality investigations, and more. Providing quality oversight for Facilities, Utility Systems, Equipment (FUSE) Qualification in addition to instrument qualifications (AIQ) and Computerized Systems Validation/Assurance (CSV/CSA), while applying risk-based methodology to validation and qualification efforts according to GxP regulations. Overseeing Quality System/Equipment implementations and all activities related to Analytical Development method projects. Providing oversight of quality of activities and quality records to include deviations, CAPAs, and change controls, within GxP Facilities, Utilities, Equipment, Analytical Instruments, and Computerized Systems. Driving data integrity best practices and awareness across the Data Integrity Program while ensuring maintenance and compliance across the entire data lifecycle for GxP Operations. Supporting continuous quality systems improvements by authoring new and existent procedures and forms. Requirements: BS Degree or similar area of study. Availability to be onsite within a hybrid role 2 to 3 days weekly; meaning local to the area. 3+ years hands-on QA expertise within a Biotech or pharma organization and within a GxP environment. Proficiency in all Microsoft Office Applications. Lab Systems and Veeva are both a plus. A 6-month hybrid contract with potential extensions. The opportunity to work W2 with or without benefits or 1099. Seniority level
Seniority levelAssociate Employment type
Employment typeContract Job function
Job functionQuality Assurance, Science, and Consulting IndustriesBiotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing Referrals increase your chances of interviewing at The Planet Group by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Get notified about new Quality Assurance Specialist jobs in
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Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants. Base pay range $42.00/yr - $55.00/yr Direct message the job poster from The Planet Group Quality Assurance Senior Specialist – (Contract) – Hybrid - CA California Biotech seeks a Quality Assurance Senior Specialist for a hybrid contract opportunity near Fremont for a 6-month contract with possible extensions. The ideal candidate will have 3+ years’ hands-on QA experience working within Quality Systems in a GxP regulatory environment. This includes Utilities, Facilities, Equipment, Analytical Instruments and Computerized Systems. Additionally, this person must have experience in data integrity programs while interacting cross-functionally with QC, Manufacturing, Facilities, IT, Supply Chain and Regulatory Affairs.
Opportunity requires hybrid onsite meaning LOCAL CANDIDATES ONLY & NO RELOCATIONS FOR PROJECT. Responsibilities Performing various QA activities while ensuring compliance with organizational procedures and US/International regulatory requirements for drug products. Coordinating and tracking closure of quality records to include change controls, deviations, CAPAs, quality investigations, and more. Providing quality oversight for Facilities, Utility Systems, Equipment (FUSE) Qualification in addition to instrument qualifications (AIQ) and Computerized Systems Validation/Assurance (CSV/CSA), while applying risk-based methodology to validation and qualification efforts according to GxP regulations. Overseeing Quality System/Equipment implementations and all activities related to Analytical Development method projects. Providing oversight of quality of activities and quality records to include deviations, CAPAs, and change controls, within GxP Facilities, Utilities, Equipment, Analytical Instruments, and Computerized Systems. Driving data integrity best practices and awareness across the Data Integrity Program while ensuring maintenance and compliance across the entire data lifecycle for GxP Operations. Supporting continuous quality systems improvements by authoring new and existent procedures and forms. Requirements: BS Degree or similar area of study. Availability to be onsite within a hybrid role 2 to 3 days weekly; meaning local to the area. 3+ years hands-on QA expertise within a Biotech or pharma organization and within a GxP environment. Proficiency in all Microsoft Office Applications. Lab Systems and Veeva are both a plus. A 6-month hybrid contract with potential extensions. The opportunity to work W2 with or without benefits or 1099. Seniority level
Seniority levelAssociate Employment type
Employment typeContract Job function
Job functionQuality Assurance, Science, and Consulting IndustriesBiotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing Referrals increase your chances of interviewing at The Planet Group by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Get notified about new Quality Assurance Specialist jobs in
San Francisco Bay Area . Quality Assurance Manager, Product QualityQuality Assurance Specialist I - Therapeutics San Mateo, CA $140,000.00-$170,000.00 1 month ago San Francisco, CA $120,000.00-$140,000.00 3 days ago Newark, CA $77,500.00-$97,000.00 2 weeks ago San Mateo, CA $68,700.00-$75,000.00 1 week ago SR. Moderator, Quality Control & Labeling- ContractorSpecialist, Quality Assurance Operations Alameda, CA $90,000.00-$100,000.00 4 days ago San Mateo County, CA $60.00-$65.00 1 week ago San Leandro, CA $105,000.00-$120,000.00 6 days ago Quality Assurance Quality Control Manager (Process Piping) San Leandro, CA $170,000.00-$180,000.00 2 months ago Stockton, CA $115,000.00-$130,000.00 2 weeks ago Quality Assurance Manager, eero B2B teamQuality Assurance Manager, eero B2B team Alameda, CA $98,000.00-$196,000.00 1 week ago Junior QA Engineer - Awesome Recent Grad OpportunityJunior Quality Assurance Analyst (Software) San Francisco, CA $75,000.00-$100,000.00 5 days ago San Leandro, CA $68,000.00-$85,000.00 4 days ago Alameda, CA $86,700.00-$173,300.00 1 week ago Sunnyvale, CA $147,000.00-$170,000.00 1 month ago Palo Alto, CA $140,000.00-$170,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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