Hello,
We are having the below requirement for you.
Please go through the requirement and let me know your interest.
*Contract Position: QA Associate*
*Work Location: Mountain View, CA*
*Client: Hitachi Chemical*
*Duration: Permanent*
We are seeking highly motivated Quality Assurance Associates who are
interested in joining our fast-paced, dynamic environment.
The Quality Assurance Associate performs Quality Assurance activities with
minimal if any supervision of daily tasks in support of Quality Systems
and/or client procedures including but not limited to document management,
issuance, review and approval of batch records, QC data, SOPs, material
releases and final product releases. The ideal candidates for these
position also assists Quality management with department needs.
*Responsibilities:*
- Ensures the safe release of cellular products in accordance with
company and/or client procedures and requirements.
- Ensure and promote compliance with applicable CGMP and GTP regulations
and company and client SOPs
- Able to provide input based on knowledge and experience on quality
systems and procedures and CGMP/GTP issues.
- Author and review relevant SOPs, validation and other documents.
- Responsible for the timely issuance, review and approval of QC
certificates, closure of Batch Records, and deviation reports.
- Responsible for the completion of all client requirements related to
cellular product and/or material releases.
- Master Batch Record Control, distribution and label verification
- Perform line clearance activities as required.
- Assignment and maintenance of product Lot numbers as applicable.
- Perform internal documentation audits as assigned.
- Materials management nonconformance disposition and release activity
as applicable.
- Responsible for accurate deviation reporting as applicable and
tracking/trending follow up actions to closures
- Evaluate and investigate deviation reports and initiate and coordinate
corrective and preventive actions.
- Track and trend relevant quality metrics including environmental
monitoring data.
- Provide Quality Assurance related support to various departments.
- Interface with suppliers and in-house production personnel to ensure
effective corrective and preventive actions are implemented for recurring
product/process discrepancies.
- Electronic Document Control activities as assigned.
- Provide training to personnel as assigned by supervisor.
- Travel may be required.
*Knowledge and Experience:*
- Bachelor's Degree in biological sciences or a relevant field required
- *BS (or equivalent) in a scientific related field with 3-6 years
of experience in the pharmaceutical/biotech industry*
- *Minimum of 3 years in Quality Assurance, preferably in the
biologics field*
- *Working knowledge and technical understanding of the manufacture
and testing of biologics preferred*
- *Working knowledge of cGMP principles with respect to FDA and EMA
regulations*
- *Working knowledge of cGCP and cGTP a plus*
- Must have a strong understanding of current Good Manufacturing
Practices (cGMPs) and Good Laboratory Practices (GLPs)
- Working knowledge of routine laboratory operations, equipment and
systems, production processes, validation, etc. preferred
- Applicable or related experience in a clinical laboratory, hematology,
blood banking, immunology or QA laboratory preferably in a CGMP/GTP
environment
- Sound knowledge of aseptic processing and supporting technologies
- Analytical and technical trouble-shooting skills are a plus
- Strong team-oriented, interpersonal skills are essential
- Excellent organizational skills and attention to detail
- Good verbal and written communication skills
Best Wishes,
*Shravan, Senior Recruiter*
*+1 (650) 353-3227*
*shra...@wittaff.com <shra...@vedasoftwaresolutions.com>*
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