Quality Systems Specialist
Company: Integrated Resources Inc
Location: Rocklin
Posted on: May 9, 2024
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Job Description:
*Job Title Quality Systems Specialist**Job Location Rocklin,
CA**Job Duration 12+ Months (Possibilities of extension)**Pay
range: $28- $30/hr. on W2**Job description:**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:o Stability
protocols and reportso Summary of Safety and Performance reportso
Risk Management plans, reports, FMEAso Post-Market Surveillance
plans and reportso Performance evaluation plans and reports
including scientific, clinical, and analytical documents.o Product
composition reportso Sensitivity and specificity/Repeatability and
reproducibility reportso Specification reportso General Safety and
Performance Requirement reportso 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. 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.*Requirements/Qualifications:* Bachelors degree in any
life science, GMP, Pharma industry experience. At least 1 year of
experience.#IRI-LSJob Type: ContractPay: $28.00 - $30.00 per
hourWork setting:* In-personWork Location: In personby Jobble
Keywords: Integrated Resources Inc, Laguna , Quality Systems Specialist, Other , Rocklin, California
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