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Director of Quality - ChemRite

Director of Quality - ChemRite

Lewis & Clark CapitalLannon, WI, US
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Job Description

Job Description

The Director of Quality plans, directs and coordinates the quality activities of Chemrite Copac LLC to achieve maximum quality and customer satisfaction while balancing and maintaining optimal usage of resources. They ensure adherence to all regulatory requirements that the organization is subject to, and they lead the development and implementation of all related process across the organization

Listed below are the basic qualifications, required skills and competencies.

Basic Qualifications - Required :

  • Minimal BS degree in Chemistry, Biology, Quality Engineering, or other health related sciences.
  • 3-5 years of experience managing a quality assurance department in a manufacturing environment.
  • Deep knowledge of cGMP, FDA regulations, and CFR 21 compliance.
  • Experience with successful implementation and oversight of compliance programs.
  • Track record of leading quality assurance teams and managing audits, inspections, and regulatory submissions.
  • Is an analytical and decisive decision maker.
  • Has the ability to generate respect and trust from staff and external contacts.

Basic Qualifications - Preferred :

  • Lean Manufacturing, Six Sigma certifications, Certified Quality Auditor (ASQ CQA), or Certified Quality Engineer (ASQ CQE)
  • Has bilingual English and Spanish skills.

    • Required Skills : LEADERSHIP :

  • Manages daily activities of the Quality Assurance, Quality Control, Document Control, and Compliance departments.
  • Proactively communicates with all department supervisors to achieve quality and compliance standards.
  • Creates and monitors the monthly quality metrics and reports to management the monthly performance scores.
  • Completes performance reviews for the quality unit on an annual basis.
  • Reports to management on quality issues and trends (i.e., deviations, QA reporting, customer complaints, etc.)
  • Carries out supervisory responsibilities in accordance with the organization''s policies and applicable laws.
  • Responsible for interviewing, hiring, and training new employees.
  • Ability to foster a culture of accountability.

    • REGULATORY :

  • Oversees compliance with all regulatory bodies governing quality, environmental, health, and safety. Includes but is not limited to the FDA, EPA, OSHA, DNR, State, and Federal regulations.

    • QUALITY ASSURANCE :

  • Prepares and facilitates customer and regulatory audits and or inspections.
  • Reviews and approves changes to quality documents as necessary (i.e. QARMs, QAFGs, QAPMs, manufacturing records, project folders, QSM SOPs, etc.)
  • Responsible for monitoring validation program. This includes cleaning validations, process validations, method validations, and equipment validations.
  • Proposes, updates and enforces Quality Assurance policies and procedures (SOPS).
  • Maintains oversight of the Vendor Qualification process and maintains the Approved Supplier List.
  • Audits Quality System and vendors following audit guidelines.
  • Ensure change control process is being followed.
  • Investigates and writes all types of deviations, non-conforming products, and customer complaint reports.
  • Interacts directly with customers regarding quality related issues.
  • Investigates, develops, and recommends changes to processes and procedures to drive continuous quality improvement.
  • Completes annual product review.
  • Coordinates and facilitates third party audits when necessary.

    • BUSINESS DEVELOPMENT :

  • Works and collaborates with the sales and production team to review new business opportunities, develop new manufacturing processes, and onboard new customers.
  • Ensures quality documentation is correct and in place for new business onboarding and is accomplished following efficient established procedures.

    • Required Competencies :

    Communication / Interpersonal Skills : interacting respectfully and professionally.

  • Communicates respectfully with people at all levels both internally and externally.
  • Gathers and gives relevant information to others in a timely manner (co-workers, customers, vendors).
  • Actively participates in group discussions and brings ideas to management's attention.

    • Organizational Commitment : aligning behavior with Company needs and priorities

  • Acts consistently with company values and norms; effectively uses organizational guidelines and procedures to solve problems.
  • Actively supports and implements company decisions. Places shared goals before narrower interests.
  • Demonstrates good judgment in decision making and pursues win-win outcomes.

    • Managing People : managing others fairly and consistently

  • Sets clear expectations and gains agreement on desired actions.
  • Holds employees accountable for tasks and assignments; quickly reinforces or redirects performance when appropriate.
  • Completes annual review with each direct report; clearly addresses action items to enhance performance.
  • Regularly documents direct report's performance throughout the year, particularly when disciplinary action is required
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    Director Of Quality • Lannon, WI, US

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