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: $22 - 27 per hour
work hours: 9 to 5
education: High School
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 (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
- 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.
qualifications:
Required:
- High School Diploma
- 1 year experience reviewing documents in a GMP setting OR 1 year experience in a quality role within a GMP setting
- Bachelors degree in any life science
- Experience with technical documentation for product design
skills: SOP, Quality Assurance, GLP (Good Laboratory Practice), 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.
