- 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)
