QA Specialist II

Quality Assurance Specialist II

Why Yoh? Yoh knows greater talent, that’s why.

We are looking for a highly motivated QA Specialist II to join the Quality team. As the newest addition to the growing team, your technical and rigorous approach will be focused on Quality oversight of manufacturing activities such as Labeling Approval, AQL/Quality Inspection, Effectiveness of Blinding, QA Retention Samples, SLE, SM Bottling Operations, Warehouse Management, and Discrepancy Management.

This role would suit a successful BS graduate in a scientific discipline with 2-4 years of experience in QA or QC, as well as must hold thorough knowledge of cGMP regulations and manufacturing processes.

Yoh is in a unique position, we have to find the best technical talent, provide services to some of the world’s largest companies, and be a great employer. We do that with the great people we have working for us. This QA Specialist opportunity is with our client in the South San Francisco, CA area. This client is globally recognized as a leader in clinical diagnostics innovation.

We strive to be a company that embraces diversity, is inclusive, and thrives on learning so that our employees feel respected and invited to contribute to the success of our company, clients, suppliers, and communities.

Your Contribution
Essential Functions

• Provide Quality oversight of manufacturing activities such as Labeling Approval, AQL/Quality Inspection, Effectiveness of Blinding, QA Retention Samples, SLE, SM Bottling Operations, Warehouse Management, and Discrepancy Management.
• Create, revise, review, and approve controlled documents relating to processes, equipment, and facilities in the manufacture of products.
• Oversight of pest control of IMP GMP areas.
• Review and approve change records.
• Represent Quality Assurance on local and cross-functional project teams.
• Assist with discrepancy investigations.
• Interact with interdepartmental contacts on discrepancy assessment, resolution, and quality approval.
• Assist with manufacturing facility and equipment start-up/changeover/tooling activities.
• Administer the change control and discrepancy management programs, ensuring that each program is consistent with current regulatory and industry guidelines.
• Collaborate with other departments to ensure that all review activities are executed efficiently and effectively.
• Troubleshoot and initiate the resolution of Quality issues by fostering effective cross-functional partnerships.
• Independently manage competing priorities with limited instructions.
• Able to train other personnel. Revise and create training materials.
• Provides guidance and leadership to more junior peers to help with resolving more complex issues and problems.
• Perform continuous GMP training
• Accomplish corporate and departmental goals
• Participate and support internal and external audits.
• Serve as Subject Matter Expert to defend the MQA activities.

 

Your Accomplishments
Required Skills

• B.A. or B.S. degree (preferably in Life Science) plus 2-4 years of work experience. A minimum of at least two years of experience in Quality Assurance, Quality Control, Manufacturing, or equivalent experience.
• Thorough knowledge of cGMPs, and regulations applicable to U.S. and international Regulatory agencies.
• Excellent verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills are essential.
• Must be able to apply cGMP concepts and requirements in order to assist with product release and use sound judgment and decision-making skills.
• Familiarity with computer systems and ability to quickly become familiar with new software (e.g., EDMS, LIMS, SAP, Trackwise, and Microsoft Office) is highly desirable.
• Demonstrate excellent problem solving skills, tactical strategy, and diplomacy.
• Implement and maintain the Pharmaceutical Quality System (PQS) within the department and for relevant functions supported by PTQD.

Your Benefits & Compensation
Compensation: $35 – 45/hr, depending on experience. 
Contract Length 12-Months w-possibility of extending
Benefits

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance

Opportunity is Calling, Apply Now! | Email Resume/CV to Amber Meza, Amber.Meza@yoh.com

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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 to contact us if you are an individual with a disability and require accommodation in the application process.