Quality Assurance & Lab Manager LOC : Pasadena, TX

Quality Assurance & Lab Manager LOC : Pasadena, TX

  • Posted on : 09-08-2023
  • Job Type : Full Time only
  • Salary : 100,000 - 200,000

Job Description:

  • 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


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