QC Analyst -Jobs in Washington
Description
Job Number:
00514
QC Analyst II
Primary Location
: WA-Bothell
Organization
: Product Supply – Manufacturing
Schedule
: Full-time
Shift
: Day Job
Description
:
Bayer HealthCare Pharmaceuticals is a leading global specialty pharmaceutical and biotechnology company. With over $3 Billion in protein drug sales, Bayer ranks as the sixth largest biotech company in the world.
The Bothell, WA facility is currently hiring for a QC Analyst II. The QC Analyst II performs analytical testing of raw materials used in the GMP manufacture of Leukine to verify their identity and quality. Assurance of raw material quality is essential both for regulatory compliance and minimization of business risks involved in biopharmaceutical manufacture.
The QC Analyst II will be tasked with and responsible for, but not limited, the following:
* Following cGMP practices
* Raw Materials inspection, sampling, and analytical testing per compendial monographs and in-house SOPs
* Peer review of data
* Results entry and verification in SAP and LIMS databases
* Periodic review and revision of SOPs
* Performing scheduled and corrective maintenance of analytical instruments
* Logging receipt of environmental monitoring samples
* Executing instrument qualifications
* Other projects as needed
Work Relationships:
* QCRM staff are often called upon to collaborate with each other to optimize lab techniques, and will also perform review of their peer’s work.
* QCRM staff have direct contact with our internal customers in Materials Management and Production to update them on the disposition status of materials.
* QCRM staff also work with Quality Assurance to document SOP revisions, lab investigations, and deviations, when they occur.
* QCRM staff may also maintain relationships with suppliers of raw materials to obtain information relevant to the quality of the products purchased by Materials Management.
Qualifications
:
* BA/BS degree in Biology, Microbiology, Chemistry, Biochemistry or related science
* 1-3 years experience in a cGMP Quality Control analytical laboratory in a regulated environment, preferably in the Pharmaceutical industry
*
Understanding of cGMP principles
*
Concise and accurate verbal and written communication skills
*
Familiarity with compendial (USP/NF, ACS) testing methods
*
Proficiency in any or all of the following techniques: pH testing, UV/Vis spectrophotometrey, FTIR spectrometry, GC, HPLC, manual and automated titrations, Karl Fischer coulometry, Total Organic Carbon testing, conductivity measurement, elemental analysis, density testing, refractive index testing, polarimetry, chemical identity testing
*
Regulation knowledge and environmental requirements
*
Experience with aseptic technique and tissue culture
Relevant experience may supersede degree requirements. The preceding statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personal so classified.
http://bayer.taleo.net/careersection/2/jobdetail.ftl?lang=en&job=54572
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