CooperSurgical is a globally provider of more than 600 products, each with a focus on improving the health of women, babies and families additionally is a Premier Provider of Medical Devices, Fertility and Genomics Solutions.
Manage the Quality Control team responsible for incoming inspection of raw materials and QC testing of finished good items.
Oversee the qualification and validation activities for the quality control department.
This involves coordination, review and approval of protocols and reports for the qualifications/validations related to the analytical equipment and methods for the QC lab.
Ensure equipment is installed and maintained functional through internal and external preventive maintenance programs and proper training of employees.
Ensure team is trained and SOPs are updated and accurately reflects processes in the department.
Also maintain the QC validation master plan to ensure activities are executed and reported timely.
Drive continuous improvement activities.
Participate and/or lead CAPA, NCMR processes DMAIC problem solving activities.
Develops metrics to monitor equipment and process performance such as Release on time, control charts, capability indices, etc.
Setup of QC test specifications in QMS and ERP system together with R&D and Engineering.
Coordinate execution of stability studies in collaboration with R&D.
Ensure compliance to industry standards and safety regulations for handling and disposing of test samples and reagents.
Perform other tasks as directed by management.
Measures of performance Testing and release of products on time Ability to manage multiple commitments and competing priorities Ability to identify and resolve project as well as operational problems – both individually and as facilitator of team.
Ability to analyze situations and make good decisions with team, peers and manager.
3-5 years of experience from lab manager, team leader or supervisory role in an analytical or microbiological laboratory is a must.
Bachelor's degree in chemistry, chemical engineering, material engineering, biomedical engineering, microbiology or similar is required Master's degree in chemistry, chemical engineering, material engineering, biomedical engineering, microbiology or similar is desirable.
In-depth understanding of analytical equipment and methods, equipment qualification and analytical method validation is required.
Experience with pH, osmolality, ELISA, Viscosity, Density, RP-HPLC, endotoxin testing and sterility testing is an advantage.
Solid understanding of aseptic medical device manufacturing or pharmaceutical manufacturing.
FDA and GMP experience is a must.
Knowledge of microbiology and experience with environmental monitoring of clean rooms is desired.
Creative individual who is able to communicate and coordinate good ideas through to implementation.
Fluent in Spanish.
Strong written and oral communication skills in English as most reports and presentations will be in English.
Skilled with MS Word, Excel, Power Point.
Experience with Six Sigma Green Belt and solid understanding of Lean Principles, CAPA, and DMAIC problem solving process is desired.
#LI-AP1
