Quality System Specialist II - Yoh
Richmond, CA 94801
About the Job
*Quality Systems Specialist II*
*Richmond, CA- Onsite*
*6 month W2 contract (with potential to extend or transition to perm)
Pay rate: $35-45/hour - Depending on Education and Experience*
*Summary:*
You will work as a Quality Systems Specialist under the Northern California Quality Assurance Operations team, you will support manufacturing activities including investigations of product non- conformance and deviations, blocking of non- conforming material, batch record and CoA review and release. Leveraging your knowledge of Quality principles, you'll guide the manufacturing partners in correct path for cause investigation and issue resolution. You'll provide feedback on best practice for documentation and Quality record updates to reinforce the Quality Management System.
*Responsibilities:*
* Support Bio-Rads top business priority: 3110 BioPharma Demand
* Support batch release for LSG mfg sites
* Support Veeva integration for NorCal (Change Control, Nonconformance Management)
* Verification of Change Control activities
* Rapid containment of product quality issues (either from manufacturing issue or a customer complaint issue)
* Audit preparedness, to reduce audit findings
*Skills or Requirements: *
* Understanding of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).
* Working knowledge of device/drug/biotech manufacturing processes.
* Detail-oriented, excellent organization and project management skills and ability to multitask.
* Decision making, time management, organization, communication, leadership, and computer skills.
* Proficient in Microsoft Office, Visio and Excel SalesForce and SAP experience is a plus
*Education:*
* Associate degree or equivalent in Biology, Chemistry, or related field.
* 2+ years experience in a regulated manufacturing industry or equivalent combination of education and experience.
*What's In It For You?*
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
* Medical, Dental & Vision Benefits
* 401K Retirement Saving Plan
* Life & Disability Insurance
* Direct Deposit & weekly ePayroll
* Employee Discount Programs
* Referral Bonus Programs
*Estimated Min Rate*: $31.50
*Estimated Max Rate*: $45.00
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit *[https://www.yoh.com/applicants-with-disabilities ](https://www.yoh.com/applicants-with-disabilities)
*to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
*Richmond, CA- Onsite*
*6 month W2 contract (with potential to extend or transition to perm)
Pay rate: $35-45/hour - Depending on Education and Experience*
*Summary:*
You will work as a Quality Systems Specialist under the Northern California Quality Assurance Operations team, you will support manufacturing activities including investigations of product non- conformance and deviations, blocking of non- conforming material, batch record and CoA review and release. Leveraging your knowledge of Quality principles, you'll guide the manufacturing partners in correct path for cause investigation and issue resolution. You'll provide feedback on best practice for documentation and Quality record updates to reinforce the Quality Management System.
*Responsibilities:*
* Support Bio-Rads top business priority: 3110 BioPharma Demand
* Support batch release for LSG mfg sites
* Support Veeva integration for NorCal (Change Control, Nonconformance Management)
* Verification of Change Control activities
* Rapid containment of product quality issues (either from manufacturing issue or a customer complaint issue)
* Audit preparedness, to reduce audit findings
*Skills or Requirements: *
* Understanding of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).
* Working knowledge of device/drug/biotech manufacturing processes.
* Detail-oriented, excellent organization and project management skills and ability to multitask.
* Decision making, time management, organization, communication, leadership, and computer skills.
* Proficient in Microsoft Office, Visio and Excel SalesForce and SAP experience is a plus
*Education:*
* Associate degree or equivalent in Biology, Chemistry, or related field.
* 2+ years experience in a regulated manufacturing industry or equivalent combination of education and experience.
*What's In It For You?*
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
* Medical, Dental & Vision Benefits
* 401K Retirement Saving Plan
* Life & Disability Insurance
* Direct Deposit & weekly ePayroll
* Employee Discount Programs
* Referral Bonus Programs
*Estimated Min Rate*: $31.50
*Estimated Max Rate*: $45.00
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit *[https://www.yoh.com/applicants-with-disabilities ](https://www.yoh.com/applicants-with-disabilities)
*to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Source : Yoh
