Kloudhire

The Quality Assurance & Lab Manager is responsible for ensuring quality control of hydrogen peroxide, ensuring safe and efficient operations of the laboratories, contributing to process improvement efforts, and assisting the Quality Director as required.
The Quality Assurance & Lab Manager will direct a team of lab technicians required to evaluate production performance against quality specifications in order to meet the identified needs of both internal and external customers.
The Quality Assurance & Lab Manager is also responsible for leading the sites ISO and FDA (cGMP) programs.

Requirements & Qualifications

Bachelor of Science degree in Chemistry/Chemical Engineering
Chemical industry supervisory experience is desirable
At least 3 years prior experience as a Laboratory Technician
Process, manufacturing and other technical experience and expertise are beneficial
7-8 yearsâ?? experience with managing direct reports in a similar industrial setting
Experience with clean room environment and ICP-MS is desirable
ISO management system experience required
FDA (cGMP) experience is desirable

Duties & Responsibilities

Health, Safety, Security and Process Safety
To maintain and enhance the Bayport Plants Safety and Security programs for all Laboratory Personnel to minimize injury and loss potential
To provide laboratory resources to support the activities of the Health, Safety, Security, and Process Safety programs
To ensure compliance with all state and federal safety regulations in all laboratory areas
To establish and maintain high housekeeping standards in all laboratory areas

Environmental

To ensure compliance with all state and federal environmental regulations, in all laboratory areas

Quality Control

To supervise and direct the resources required to evaluate production performance against quality specifications to meet the identified needs of internal and external customers
To direct the preparation and documentation of sample shipments
To direct the verification of incoming raw materials, in-process samples, tank samples, finished product storage and finished product shipment samples
To ensure accurate testing, reporting and record keeping of results are in place
To ensure that analytical methodologies have accuracy and precision required to meet customers needs (method validation, gage R&R, calibration, standard preparation, instrument status verification, preventive maintenance)
To maintain the instrument preventive maintenance program in good standing
To administer all clean room environment to maintain compliance to the designated ISO classification and maintain adequate clean room protocol
To maintain a reliable service by ensuring availability of critical parts and lab consumables while looking for ways to optimize instrumentation uptime
To work with instrument vendors as needed
To ensure good laboratory practices are being followed

Support Customer Service Needs

To administer the customer problem order and customer complaint database
To maintain contact with other personnel to prevent or resolve customer problems
To complete customer quality questionnaires pertaining to the ISO management system at Bayport
To ensure timely responses to audits and ensure that action items are being completed timely

Quality Assurance

To ensure the proper implementation and reporting of all quality assurance and SPC data for the control of the H2O2 processes
To serve as the ISO and cGMP (API) Coordinator for the Bayport site. Assist Saratoga Springsâ?? site with the management of their ISO management system
To manage all NSF, KOSHER, ISO, FDA (cGMP) and Customer Audit.
To draw expertise from other resources in assisting production in meeting plant performance objectives