Job Description
Job Description
Associate Quality Systems Specialist
Preferred: Bachelors degree in any life science, GMP, Pharma industry experience
At least 1 year of experience
100% on-site
Site closing Feb 2026
Ideal candidate has reviewed docs in a GMP setting or worked in a quality role in a GMP setting.
Energetic, quick learner, excellent attention to detail
Technical documentation for product design - PLUS
Job Description:
Roles that 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.
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.
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, 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
Primary Objective Of Position:
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
Adhere to regulatory requirements (including cGMP), standards, procedures, and company policies as applicate to site, i.e. MDSAP, ISO 13485, IVDR, and comply with site Quality Manual.
Directly responsible for ensuring documents submitted to Quality comply with regulatory requirements, company policies/procedures and the Quality Manual.
Performs review and audit of Device History Files (DHFs) and technical files. Examples includes Protocols and reports, i.e. Stability, verification/validation, Summary of Safety and Performance reports, Risk Management documents/record, i.e., plans, reports, FMEAs, Post-Market Surveillance plans/reports, Performance evaluation plans/reports; scientific, clinical, analytical documents, Product composition reports, Sensitivity and specificity/Repeatability and reproducibility reports, Specification reports, General Safety and Performance Requirement reports.
Coordinate files upon completion of review for upload into eDMS as necessary.
Perform review of data and records supporting DHF while assessing for good documentation and record keeping practices ensuring requirements are met.
Collaborate and coordinate with internal stakeholders to identify, escalate, and resolve quality issues.
Respond promptly to customer needs; solicit customer feedback to improve service; meet commitments
Meet productivity standards without sacrificing quality and safety
Recommend, provide, or initiate solutions by actively providing suggestions for improvement.
Review and approve quality documentation and records. Including electronically signing as technical for quality on applicable documents and within the validated electronic databases.
Write, revise and/or review procedures/instructs as necessary.
Support internal and external audits as required.
Maintain current training requirements.
Work on weekends or extended hours as needed.
Understand, support, and communicate Company mission, vision, and values.
Other duties as assigned or required.