Quality Assurance Expert

Hello,

My name is Jothi , and I am a Recruiter with The Fountain Group . We are a national staffing firm and are currently seeking a Quality Assurance Expert for a prominent client of ours. This position is located in Rocklin, CA.

If you are interested in hearing more about the position please respond to this posting with your resume attached or contact me at 813-444-6306 / jothi.kumari@thefountaingroup.com

Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.

JOB DESCRIPTION :

Title : Quality Assurance Expert

Location : Rocklin, CA

Duration : 6+ Months

Hourly Rate on W2 : $27.00

Ideal candidate has reviewed docs in a GMP setting or worked in a quality role in a GMP setting.

The Associate Quality Systems Specialist provides quality support of the site quality management system, 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 focusing on future products, current products, and process improvements.

Representing Quality on cross-functional teams to support business needs driving a positive site quality culture may be required.

Prepare Quality System documents and reports as needed for Rocklin site metrics and management review

Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual

Performs project review and audit of Device History Files (DHF's)

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.

Maintain cGMP compliance in the laboratory

Write, revise, and / or review Standard Operating Procedures

Maintain extensive knowledge of Standard Operating Procedures and GMP regulations and policies

Support internal and external audits as needed

Responds promptly to customer needs; solicits customer feedback to improve service; meets commitments.

Understand and follow the requirements of the quality system

Maintain current training requirements

Trains other staff members as requested

Adhere to regulatory requirements (including cGMP), standards, procedures, and company policies

Recommend, provide, or initiate solutions by actively providing suggestions for improvement

Collaborate and coordinate with internal stakeholders to identify, escalate, and resolve quality issues

Understand, support, and communicate Company mission, vision, and values

Other duties as assigned or required to support the business

Must be willing and able to work on weekends or extended hours as needed