What are the responsibilities and job description for the Quality Assurance Specialist position at Primary Talent Partners?
Primary Talent Partners has a new Quality Assurance Specialist position with our large medical device client in the Hayward, CA area. This will be a three month FT contract with high potenital to extend and/or convert.
Pay: $30 - $35/hr based on experience; W2 contract, no benefits, no PTO
Schedule: M to F, 7:30am - 4pm
Description:
This position is responsible for supporting the batch release department. Responsibilities of the department include review and release of all batch production records. Provide quality support and guidance to all manufacturing groups.
Essential Duties and Responsibilities:
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
#PTPJobs
Pay: $30 - $35/hr based on experience; W2 contract, no benefits, no PTO
Schedule: M to F, 7:30am - 4pm
Description:
This position is responsible for supporting the batch release department. Responsibilities of the department include review and release of all batch production records. Provide quality support and guidance to all manufacturing groups.
Essential Duties and Responsibilities:
- Ensure timely QA review and release of in-process and finished goods documentation to verify compliance to SOPs and regulatory requirement.
- Write, revise and review SOPs.
- Perform QA on the floor activities (e.g. verifications, inspections, etc.).
- Ensure quality and consistency in documentation and adherence to SOPs.
- Maintain expertise in quality system (e.g. change control, critical system, etc.) and ability to initiate and execute change control requests.
- Assist with continuous improvement initiatives / projects.
- Participate in internal or external audits and support audit observations as needed.
- Ensure training requirements are met and records are up to date.
- Maintain and update departmental metrics and reporting.
- Work closely with the Manufacturing department to provide on-going Quality support.
- Represent QA at cross-functional meetings, providing QA input and decision making.
- Provide training to group and departments when needed.
- Assist department supervisor/manager with workload/activity scheduling
- Work with department supervisor/manager to identify and drive improve opportunities. Skill and knowledge with lean manufacturing tools and six sigma methodologies necessary to analyze and improve business processes.
- Must be very detail oriented with a high quality of work.
- Knowledgeable in current Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
- Working knowledge of FDA regulations (Part 820, 211), ISO 13485, and other applicable regulations.
- Must demonstrate effectiveness in ability to train others, drive results, and meet deadlines.
- Proficient in Microsoft Office applications (e.g. Word, Excel, etc.).
- Application of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
- Demonstrated attention to details and accuracy, required.
- General knowledge of quarantine and warehouse operation helpful. May be required to work flexible hours, as needed.
- Bachelor’s degree in relevant discipline or equivalent experience
- Experience with applicable medical device (21CFR820, ISO 13485, CMDR, MDD) and/or biologics regulations desirable.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
#PTPJobs
Salary : $30 - $35
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