Quality Assurance Specialist

• 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 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)