{"id":200,"date":"2022-11-06T10:27:43","date_gmt":"2022-11-06T15:27:43","guid":{"rendered":"http:\/\/www.cloudstaffingpro.com\/bloga\/?post_type=awsm_job_openings&#038;p=200"},"modified":"2022-11-06T10:27:44","modified_gmt":"2022-11-06T15:27:44","slug":"qa-specialist","status":"publish","type":"awsm_job_openings","link":"https:\/\/www.cloudstaffingpro.com\/bloga\/jobs\/qa-specialist\/","title":{"rendered":"QA Specialist"},"content":{"rendered":"\n<p><\/p>\n\n\n\n<p>Location: Southern California <\/p>\n\n\n\n<p>Duration: 3-6 Months<\/p>\n\n\n\n<p>The\u00a0client is looking for a QA specialist (3-5 years experience) to review manufacturing batch records, analytical testing results, and investigation reports for compliance with internal policies and procedures, applicable regulatory guidelines, and phase appropriate CGMPs, with minimal supervision.\u00a0<\/p>\n\n\n\n<ul><li>Review and approve new production batch records and completed production batch records.<\/li><li>Review specifications and stability protocols for accuracy and completeness<\/li><li>Responsible for reviewing Analytical methods, protocols, and validation reports.<\/li><li>Responsible for reviewing Quality Events (e.g. deviations, NCMRs, CAPAs, OOSs, and complaints) to ensure appropriate investigations are completed timely.<\/li><li>Conduct quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness. Use of quality tools, such as 6Ms, 5-Why&#8217;s, FMEA&#8217;s, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.<\/li><li>Review change control requests to ensure the appropriate documentation is in place for changes in materials, equipment, processes, procedures, etc.&nbsp;<\/li><li>Work with cross functional teams and vendors to ensure timely completion of documentation reviews.&nbsp;<\/li><li>Perform other duties, as assigned.<\/li><li>Minimum, Bachelor&#8217;s Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc)<\/li><li>Quality professional with a minimum of 3-5 years relevant experience in the biotech industry.<\/li><li>Requires knowledge of CGMPs regulations (e.g. ICH Q7, Q9, and Q10, 21 CFR 210-211)&nbsp;<\/li><\/ul>\n\n\n\n<ul><li>3-5 years of experience in the Biotech or Pharmaceutical Industry, or relevant comparable background<\/li><li>Knowledgeable in Biotech\/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory<\/li><li>Detail oriented with strong analytical, written, verbal communication and interpersonal skills<\/li><li>Experience with Veeva Vault, Master Control or similar Electronic Data Management Systems preferred.<\/li><li>Strong background in Good Documentation Practices is required. Must be computer literate.<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Location: Southern California Duration: 3-6 Months The\u00a0client is looking for a QA specialist (3-5 years experience) to review manufacturing batch records, analytical testing results, and investigation reports for compliance with internal policies and procedures, applicable regulatory guidelines, and phase appropriate CGMPs, with minimal supervision.\u00a0 Review and approve new production batch records and completed production batch [&hellip;]<\/p>\n","protected":false},"author":1,"template":"","meta":{"_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":""},"_links":{"self":[{"href":"https:\/\/www.cloudstaffingpro.com\/bloga\/wp-json\/wp\/v2\/awsm_job_openings\/200"}],"collection":[{"href":"https:\/\/www.cloudstaffingpro.com\/bloga\/wp-json\/wp\/v2\/awsm_job_openings"}],"about":[{"href":"https:\/\/www.cloudstaffingpro.com\/bloga\/wp-json\/wp\/v2\/types\/awsm_job_openings"}],"author":[{"embeddable":true,"href":"https:\/\/www.cloudstaffingpro.com\/bloga\/wp-json\/wp\/v2\/users\/1"}],"version-history":[{"count":0,"href":"https:\/\/www.cloudstaffingpro.com\/bloga\/wp-json\/wp\/v2\/awsm_job_openings\/200\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.cloudstaffingpro.com\/bloga\/wp-json\/wp\/v2\/media?parent=200"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}