Associate Quality Systems Specialist

Job Summary

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.

location: Rocklin, California

job type: Contract

salary: $25 - 27 per hour

work hours: 9 to 5

education: High School

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 (DHF's) 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.
  
  

Qualifications

Required:

• HS diploma/equivalent
  
  

Preferred

• Bachelors degree in any life science
• GMP & 1 year of Pharma industry experience
  
  

skills: GMP (Good Manufacturing Practice)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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