GMP Quality Assurance Specialist at The Fountain Group
Rocklin, CA
About the Job
Immediate opening for a Quality Assurance Specialist located in Rocklin, CA (Onsite).
Details for the position are as follows:
Job Description:
Who We Are:
The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.
Browse our website below for additional information on our company.
The Fountain Group
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”
Details for the position are as follows:
Job Description:
- Performs project review and audit of Device History Files (DHF's) 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 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.
- 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. Uses clearly defined procedures to perform basic, repetitive, manual tasks.
- Accountable for efficiency and accuracy of own routine day-to-day task execution; works under close supervision with little autonomy.
- 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.
- Shift Schedule: Monday – Friday, 40hrs./week
- Pay Rate: 20 – 27/Hour
- High School Diploma/Ged, Minimum Required
- 1+ Years Experience in GMP Environment (Pharma/Biotech/Med Dev, Preferred)
- Experience with reviewing and ensuring quality of documentation/reports (SOPs, DHFs, BRs, etc.)
- Team Collaboration, Organized, Detail-Oriented
- Contract to Start, conversion/extension on performance
Who We Are:
The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.
Browse our website below for additional information on our company.
The Fountain Group
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”
