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Form of workAssociate Quality Systems Specialist
Job Description:
Primary Objectives:
Essential Duties and Responsibilities:
Impact:
Complexity:
Accountability /Independence:
Required Experience:
Organization:
Benefits:
About the Company:
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- Contract Duration 6 Months
- Pay range - $26 to $27/hr
Job Description:
- Associate Quality Systems Specialists are responsible for the analysis, development, and operation of quality and risk management systems.
- Activities include developing standards for quality, documentation, and processes as well as continuous improvement and preventive activities.
- Conducts analytics to ensure that the company's products are according to defined quality standards.
Primary Objectives:
- The Associate Quality Systems Specialist will be part of the Quality team and responsible for providing quality support for the site quality management system.
- This position ensures compliance of the quality system with regulations relevant to the business, including but not limited to, ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP, and the quality manual.
- This position is multi-disciplinary with opportunities to work on future products and current product and process improvements.
- The position may represent Quality on cross-functional teams to support business needs driving a positive site quality culture.
- The position prepares Quality System documents and reports as needed for Rocklin site metrics and management review.
Essential Duties and Responsibilities:
- The Associate Quality Systems Specialist is directly responsible for ensuring documents submitted to Quality are compliant with company procedures, regulatory requirements, and the quality manual.
- Performs project review and audit of Device History Files (DHFs) and technical files including:
- Stability protocols and reports
- Summary of Safety and Performance Reports
- Risk Management plans, reports, FMEAs
- Post-market surveillance plans and reports
- Performance evaluation plans and reports including scientific, clinical, and analytical documents.
- Product composition reports
- Sensitivity and specificity/Repeatability and reproducibility reports
- Specification reports
- General Safety and Performance Requirement reports, etc
- Performs review of data and records supporting the DHF while assessing for good documentation and record-keeping practices ensuring appropriate requirements are met.
- Obtains information for clarification from process owners while providing appropriate and relevant feedback.
- Coordinates files upon completion of review for upload into EDMS as necessary.
- Electronically signs as a technical approver for quality on applicable documents and within the validated electronic databases.
- Write, revise, and/or review Standard Operating Procedures.
- Maintain extensive knowledge of Standard Operating Procedures and policies.
- Supports internal and external audits as required.
- Understands, supports, and communicates Company mission, vision, and values.
- Understands and follows the requirements of the quality system.
- Maintains current training requirements.
- Trains other staff members as requested.
- Adhere to regulatory requirements (including cGMP), standards, procedures, and company policies.
- Recommends, provides, or initiates solutions by actively providing suggestions for improvement.
- Must be willing and able to work on weekends or extended hours as needed.
- Follows regulatory and standard requirements as applicable to the site, i.e. MDSAP, ISO 13485, IVDD/IVDR, and compliance with the site Quality Manual.
- Review and approve quality documentation and records.
- Collaborates and coordinates with internal stakeholders to identify, escalate, and resolve quality issues.
- Other duties as assigned or required.
Impact:
- Limited impact on others.
Complexity:
- Uses clearly defined procedures to perform basic, repetitive, manual tasks.
Accountability /Independence:
- Accountable for efficiency and accuracy of own routine day-to-day task execution; works under close supervision with little autonomy.
Required Experience:
- Does not require any formal training or prior experience other than training on the job.
Organization:
- Typically reports to a Manager role or Project Manager role (for a defined period of time) based on organizational set-up, and will have a lead person for day-to-day guidance.
- Entry-level position, no prior knowledge or previous experience required.
- Typically HS diploma/equivalent is required
Benefits:
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
About the Company:
- Our client aspires to be the premier research-intensive biopharmaceutical company by using the power of leading-edge science to save and improve lives around the world. For more than 130 years, they have brought hope to humanity by developing important medicines and vaccines. Today, they are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Our client fosters a diverse and inclusive global workforce and operates responsibly every day to enable a safe, sustainable, and healthy future for all people and communities.
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