Quality Assurance Specialist

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow. Responsible for representing the department in cross functional meetings Participate in projects involving Quality Control which include new test methods Ensure compliance with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR and the Medical Device Directive. Considered a subject matter expert (SME) for test method(s) executed in the laboratory. Oversee and/or perform instrumental (i.e., UV-Vis, HPLC) and wet chemistry techniques/analyses. Oversee and/or perform laboratory testing, as well as general laboratory maintenance, including in process and final product release testing and stability testing Review test data and logbooks, report any deviations to the Supervisor Ensure timely testing and result reporting Manage sample shipment and processing with third part labs Maintain GMP/GLP laboratory notebooks and documentation relevant to the duties and responsibilities assigned. Maintain laboratory instrumentation and report any equipment issues to the Supervisor Assist as needed in test method validation, implementation, and execution. Assist in preparing for and participating in FDA audits, customer audits, etc. Complete Out of Specification (OOS) Investigations, Non-conformance Investigations (NCs), Quality Investigations (QIs), and Corrective Action/ Preventative Actions (CAPAs) Create/Revise Standard Operating Procedures (SOPs) Complete data entry for trending reports for In-process and Finished Goods Quality Control Testing, as well as Stability Testing Train and provide guidance to junior team members Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures Demonstrate excellent organizational and time management skills. Perform all other related duties required. Bachelor’s Degree in chemistry, or biological sciences, preferred 7+ years of related experience Working knowledge of standard laboratory practices and safety. Must be able to work independently with minimal supervision Capable of both written and verbal effective communication skills Experience with Microsoft Office to create reports, spreadsheets, trend data and create presentations Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus. Thank you. Kind Regards, Harris Kaushik Clinical Recruiter Integrated Resources , Inc. IT Life Sciences Allied Healthcare CRO DIRECT # - (650)-399-0891 Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5 0 0 0 ’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)