Associate Quality Systems Specialist
Rocklin CA
-12 months contract with high possibility of extension
Pay rate: $26 - $27/hr.
Experis is seeking Associate Quality Systems Specialist to join one of our Fortune 500 Life Science Client in Rocklin CA.
Work Experience/Skills:

• 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

Responsibilities :

• Directly responsible for ensuring documents submitted to Quality are compliant to 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 a 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.

• 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 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 to 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.

Education:
Preferred: Bachelor's degree in any life science, GMP, Pharma industry experience
We are looking for the candidates who are eligible to work with any employers without sponsorship.
If you're interested, please click ' Apply' button.
If you are not available or this job is not a good fit at present, please share the job details with your friends/colleagues and let me know if anyone is interested.