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Quality Assurance Leader

4 months ago

Pittsburg, United States k2 Pure Solutions Full time


k2 Pure Solutions, founded in 2010, is a Chlor-Alkali Manufacturer operating inherently safer technology to produce chemicals such as bleach for water disinfection in the surrounding Northern California communities. Bleach is the modern, preferred water treatment chemical displacing chlorine throughout the world. K2 Pure Solutions produces bleach onsite from nothing but salt, water, and electricity eliminating the danger and risk of a chlorine railcar release into communities trans-America. Other chlor-alkali products produced by K2 Pure Solutions include chlorine, hydrogen, hydrochloric acid, and caustic soda.


The Quality Assurance Manager is responsible for planning, oversight and coordination of the quality program to meet specific customer requirements. Supports plant operations by ensuring accurate analysis of K2 products, raw materials and manufacturing process samples.. Provides analytical support as needed to the operations and engineering teams. Provides management oversight of the Quality Control laboratory.


Responsibilities


  • Defines and maintains the programs and procedures necessary to maintain product quality.
  • Oversight of issuance of Certificates of Analysis.
  • Develops and implements methods and procedures for disposition of non-conforming materials. Review and approval of all investigations related to Out-Of-Specification Results and Non-Conforming Material Reviews,
  • Leads ISO 9001Management System Reviews.
  • Conducts internal audits on a regular basis necessary to confirm that quality systems are being maintained and followed.
  • Responsible for reporting to management on the effectiveness of the Quality Management System.
  • Hosts audits by customers and regulatory or certifying bodies (including ISO, NSF, etc); coordinates audit responses to all findings.
  • Oversight of Customer Complaint Program and issuance of response to the customer.
  • Champions effective Root Cause Analysis and provides oversight of the Corrective & Preventative Action Program for quality non-conformances.
  • Review and approval of process related changes for potential impact to Quality
  • Management of customer notification process as related to potential quality impacts.
  • Development and oversight of quality related employee training for onboarding and annual refresher training for all employees.
  • Responsible (owns and maintains) the facility quality manual.
  • Manages direct reports by setting goals and objectives and oversees execution of these goals and objectives.
  • Manages and supervises QC laboratory activities and laboratory personnel, coordinating daily work activities and overseeing instrument calibration and preventative maintenance programs as it relates to equipment used in the laboratory.
  • Ensures compliance with written lab and quality procedures.
  • Develops and improves analytical methods and performs measurement systems analyses to assess method capability.
  • Works with the VP and General Manager to assure compliance with Quality procedures and processes.
  • Champions continuous improvement in all Quality processes
  • Serves as site LIMS administrator.


Qualifications


·      Bachelor's degree in chemistry or related science

·      Minimum of five years experience in a Quality Control laboratory and five years experience in Quality

management with demonstrated leadership experience within the field.


Competencies


·      Working knowledge of, ISO 9001requirements and related quality standards. Familiarity with GMP and FDA requirements a plus

·      Ability to understand and organize technical data for communications and analysis.

·      Must have excellent oral and written communication skills and demonstrate the highest integrity in conducting business affairs.

·      Must exercise maturity and sound judgment in all dealings and associations with vendors and customers.

·      Must be able to work independently and to organize tasks and manage the workload.

·      Ability to deal with problems involving several variables in standardized situations, while defending decisions in a knowledgeable and rational manner.

·      Demonstrated ability to provide leadership of people and quality programs.

·      LIMS administrator experience preferred.