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QUALITY ASSURANCE SPECIALIST
Job Field: Legal Jobs
Location: Palo Alto, CA
Salary: $Not stated
Location: Palo Alto, CA
Salary: $Not stated
JOB SUMMARY:
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<tr><td valign="top" width="450"><b>id="tms_job_12-197-206">Quality Assurance SpecialistJob Code :12-197-206Division :Jazz PharmaceuticalsLocation :Palo Alto CA US 94304Job Type :Full TimeCareer Level :Experienced (Non-Manager)Education :Bachelor''s DegreeCategory :Quality SciencesJob Description :The individual will be responsible for performing key quality assurance tasks relating to pharmaceutical development and manufacture. The main focus of the work will relate to GxP activities, other than GMP. There may be some occasions, however, where work relating to commercial GMP activity will be required. The individual will work under quality assurance management at the Jazz Pharmaceuticals administrative building in Porter Drive, Palo Alto, CA, USA.Responsibilities :The individual will be responsible for supporting the clinical operations group and the drug safety (pharmacovigilance) department at the site in Palo Alto.The individual may be responsible for, but is not limited to:* Performing external GCP and GLP audits.* Performing internal audits of drug safety, clinical operations and regulatory affairs.* Conduct vendor audits and vendor site visits as required.* Support functional groups in development of standard operating procedures for all QxP activities, where required.* Work with functional groups to implement quality systems, which are required for performing activities in compliance with all relevant regulations and guidance.* Developing and reporting quality metrics.* Supporting the product complaints department, if required.* Reviewing validation protocols and reports when required.* Supporting regulatory submissions.* Acting as liaison between Jazz Quality Systems group and the functional groups for timely completion of all quality assurance related activities.* Supporting the commercial GMP operational quality group, if requested.Job Requirements :* Bachelor’s degree in chemistry, biology or a related discipline* Significant experience (3-5 years) working in pharmaceutical / biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.* Experience in auditing, both internal and external third party vendor and CRO’s.* Experience with the following desirable:* Thorough understanding of quality systems and cGxPs.* Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues.* A true self starter, who works effectively on their own initiative, and is used to working in demanding environments where there is continuous change and ambiguity.* Some travel (up to 25%) may be required.* Highly organised, with exceptional time management and prioritisation* Strong work ethic.Jazz Pharmaceuticals currently does not sponsor work permits. All eligible candidates for employment must currently be eligible to work for any employer within the United States. Jazz Pharmaceuticals is an Equal Opportunity Employer.
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<tr><td valign="top" width="450"><b>id="tms_job_12-197-206">Quality Assurance SpecialistJob Code :12-197-206Division :Jazz PharmaceuticalsLocation :Palo Alto CA US 94304Job Type :Full TimeCareer Level :Experienced (Non-Manager)Education :Bachelor''s DegreeCategory :Quality SciencesJob Description :The individual will be responsible for performing key quality assurance tasks relating to pharmaceutical development and manufacture. The main focus of the work will relate to GxP activities, other than GMP. There may be some occasions, however, where work relating to commercial GMP activity will be required. The individual will work under quality assurance management at the Jazz Pharmaceuticals administrative building in Porter Drive, Palo Alto, CA, USA.Responsibilities :The individual will be responsible for supporting the clinical operations group and the drug safety (pharmacovigilance) department at the site in Palo Alto.The individual may be responsible for, but is not limited to:* Performing external GCP and GLP audits.* Performing internal audits of drug safety, clinical operations and regulatory affairs.* Conduct vendor audits and vendor site visits as required.* Support functional groups in development of standard operating procedures for all QxP activities, where required.* Work with functional groups to implement quality systems, which are required for performing activities in compliance with all relevant regulations and guidance.* Developing and reporting quality metrics.* Supporting the product complaints department, if required.* Reviewing validation protocols and reports when required.* Supporting regulatory submissions.* Acting as liaison between Jazz Quality Systems group and the functional groups for timely completion of all quality assurance related activities.* Supporting the commercial GMP operational quality group, if requested.Job Requirements :* Bachelor’s degree in chemistry, biology or a related discipline* Significant experience (3-5 years) working in pharmaceutical / biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.* Experience in auditing, both internal and external third party vendor and CRO’s.* Experience with the following desirable:* Thorough understanding of quality systems and cGxPs.* Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues.* A true self starter, who works effectively on their own initiative, and is used to working in demanding environments where there is continuous change and ambiguity.* Some travel (up to 25%) may be required.* Highly organised, with exceptional time management and prioritisation* Strong work ethic.Jazz Pharmaceuticals currently does not sponsor work permits. All eligible candidates for employment must currently be eligible to work for any employer within the United States. Jazz Pharmaceuticals is an Equal Opportunity Employer.
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