QC Analyst III

Opportunity for a QC Analyst level III with a medical device manufacturer in Hayward, CA. This is a permanent, direct hire position with benefits. This is a day shift position (9 am -6 pm)

The summary of responsibilities includes to support Quality Control department with the In process, Final product testing, product disposition, troubleshooting, and revising procedures with other tasks necessary to meet the department scope.

Specific Responsibilities include:Responsible for leading departmental group projects related to the efficient operation of the QC lab.  Participate on cross-functional teams representing QCSchedules daily lab activities, when applicable. Provide support and guidance to other lab staffPerforms statistical analysis on test results to disposition products. Prepares documentation on test results, investigations, problems and troubleshooting noting failures using the nonconformance process.  Prepares test protocols and compiles data for documentation used with test protocol and proceduresPerform routine lab testing to support QC teamExecutes experiments, summarizes results and makes recommendations in report format to managementDevelops and revises SOPs and SWIs and other process improvement documentationReviews data and DHR for compliance to specifications and reports nonconformancePerform in-process and finished product tests using analytical equipment according to standard operating procedures.Performs routine reference instrument maintenance and calibration.  Performs daily, weekly, and monthly in-process monitoring.Stability Program development per ICH/FDA guidelines, draft final reports under appropriate guidelines

Qualifications include:Bachelor degree in a scientific discipline or technical field and 5+ years related experience in a lab environmentThorough knowledge of quality control systems, GMP/GLP, FDA QSRs and IVD industry.Solid writing skillsSolid knowledge and understanding of statistical data analysis.Solid knowledge and experience using CAR and NCR processes.Demonstrated ability to lead people and get results through others.Superior lab instrument operating skillsSolid organizational skills with the ability to manage time effectively and prioritize work.  Attention to detail is essentialSolid communication and interpersonal skills with the ability to interact at all levels. Ability to operate independently as well as part of a teamIntermediate skills using MS Office, the internet, statistical software and OutlookLaboratory skills including safety, bio-hazardous and blood borne pathogen material handling


The successful candidate will have the following:

? Statistical analysis experience is a must!

? Experience handling stability program and initiate development projects under cGMP guidelines.

? Writing SOP?s based on the stability program.

? Highly technical in running their own projects,able to take information to draft protocols and reports based on FDA/ICH guidelines.

? Knowledge of how to plan investigation, experience in documenting investigation in report format.

? Method transfer experience.

? Can-Do altitude, able to multi-task, fast learner, and technical skills in Development and QC.

? Project oriented w/ the ability to work independently or require minimum supervision.

? Big picture thinker, able to work in a team environment and flexible in working on difference projects.

? Able to ask questions and talk to upper management from other departments to seek information 

 

There is no relocation package with this position so BAY AREA RESUMES ARE PREFERRED.

If this sounds of interest to you and you would like to be considered for this position, please submit your resume AND SALARY REQUIREMENTS to Ace Recruiters at resumes@ace-recruiters.com (e-mail preferred) or  (925) 287-9002 fax.