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Meghna at 224 369 4230

Title: Quality Control Analyst I
Location: Hayward, CA
Duration: 6 Months

Summary
Conduct specific chemical and physical analysis on medical devices through all stages of the manufacturing process from incoming raw materials to finished goods. Perform investigation for microbiology and environmental monitoring.

Essential Duties and Responsibilities
Conduct chemical and physical analysis such as raw materials, in-process and finished goods products samples at Client manufacturing facility.
Conduct environmental monitoring of ISO 5, 7, 8, and 9 cleanrooms at Client manufacturing facilities along with Water collection.
QC Data entry in Sample manager- BaxLIMS
Complete all testing, including special project / protocol testing in a timely and appropriate manner.
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
Flexibility to perform other duties, as assigned, or as business needs require.
Works and communicates effectively and professionally with others inside and outside the company
Support equipment maintenance and calibrations as required.
Weekend work may be required as needed to meet production timeline schedules.

Qualifications
Ability to handle multiple tasks concurrently, and in a timely fashion.
Computer literate. Must be detail oriented, conscientious and have high reading comprehension skills.
Must have basic understanding of laboratory instrumentation.
Must be able to communicate effectively with supervisors and peers.
Must be able to read, write, and converse in English.
Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self-service applications.
Must have the ability to navigate electronic mail systems and intranet for communication purposes.
Good interpersonal skills and be able to work effectively and efficiently in a team environment.
Knowledge of cGMP manufacturing and GDP.
Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: HPLC, DSC, KF Titrator, etc.
Knowledge of equipment qualification, test method validation
Knowledge of microbiology and environmental monitoring (LAL, bioburden and EM monitoring test)
Knowledge of basic chemical and biological safety procedures.
Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
Must have passion to innovate and drive for solutions.
Must display personal accountability for results and integrity.
Must display eagerness to learn and continuously improve.
Must have uncompromising dedication to quality

Education and/or Experience
Bachelor's Degree in Chemistry, Microbiology or Biological Sciences with Analytical Chemistry or Laboratory coursework with 0-2 years' experience.

Physical Demands
Regular attendance is necessary to perform the essential functions of the job.
Light work, frequent lifting up to 10 lbs; frequent standing/walking.