QA Manager - Site Compliance

  •  

Chaska, MN

Industry: Business Services

  •  

11 - 15 years

Posted 395 days ago

  by    Benjamin Workman

Job Duties and Responsibilities

1.     Develop, maintain, and manage a lean, world-class quality system that gives the client a competitive advantage in manufacturing and regulatory compliance.

2.     •          offer leadership to constantly power improvement of all elements of the first-rate device required to help contemporary GMP's and production procedures.

3.     •          increase a strong exceptional gadget that builds high-quality and "mistakes proofing" into all procedures.

4.     •          increase distinctly predictive metrics and KPI's to make certain that proper decisions are made.

5.     •          gives guidance and interpretation on regulatory topics relevant to our commercial enterprise (e.G. FDA, CFR, USP) to help us lessen risk to our purchaser and to the corporation.

6.     •          Lead control reviews that force continuous development.

7.     •          ensure that employee education is compliant with regulatory necessities and patron expectations.

2. Manage QA functions for the Complex Value Stream manufacturing site, assuring a high degree of product quality and regulatory compliance for the value stream.

  • Provide leadership to drive continuous improvement of product quality and compliance.
  • Ensure that quality events are thoroughly and quickly investigated, driving to true root cause and effective CAPA solutions that permanently solve problems.
  • Ensure that Complex Value Stream quality processes are aligned with principles of the client's Lean Business System.

3. Develop, maintain, and manage a Facility Audit program that assures compliance and drives continuous improvement of processes, process compliance, and product quality.

  • Develop and manage audit processes that drive continuous improvement: internal, external and third party.
  • Develop criteria that will assure a state of constant readiness in the plant when followed.
  • Ensure timely execution of facility audits and provide the feedback needed to ensure readiness.
  • Ensure that customer audits build customer trust and meet customer expectations.

4. Validation – Ensure process, cleaning and equipment protocols/reports met our customer requirements, ensure FDA compliance, and produce quality products.

  • Manage and maintain Validation Master Plans that provide a high degree of compliance assurance and meet customer expectations.
  • Review and approve IQ, OQ, and PQ protocols on equipment, processes, and cleaning.
  • Review and approve IQ, OQ, and PQ reports.

5. Management Competencies - develops and maintains an organization of high performing people who are aligned with the client's Vision, Purpose, and Values.

  • Selection - finds and retains the right people in each position and selects the right candidates.
  • Training - provides employees the skill and information they need to perform their jobs successfully and follows through to ensure learning.
  • Management / Leadership - coaches employees to succeed and develops them for the future.
  • Correction / Redirection - addresses chronic unacceptable performance in a way that causes improvement.
  • Performance Evaluation - objectively values and defines performance against outcomes and standards.
  • Employee Development - follows a plan to develop performance and prepare people in their career development.
  • Termination - knows how to document employee performance and construct a case leading to correct termination decisions.

6. Understand and maintain a culture of “lean action” within the department so that the team lives lean better than any other organization.

  • Implement and maintain standards and processes that eliminate waste throughout the department.
  • Apply and utilize "lean tools" to permanently implement improvements.
  • Institutionalize 5-S in all aspects of the department. (Sort, Straighten, Shine, Standardize, and Sustain)

7. Perform other work as assigned.

Requirements

  • Bachelor's Degreerequired with a preferred major in Chemistry, Microbiology, Pharmaceutical Science or other science fields
  • 10+ years of experience in a Quality Assurance position in an effective Lean manufacturing environment within the pharmaceutical industry
  • 5+ years of experience in a Quality Assurance Manager role
  • Lean or Six Sigma Certifications preferred
  • ASQ Certification would be a plus

Job Type: Full-time

Job Location:

  • Chaska, MN

Requirededucation:

  • Bachelor's

Requiredexperience:

  • Quality Assurance: 10 years
  • Quality Assurance Manager: 5 years
  • Pharmaceutical Manufacturing: 5 years
  • Site Compliance: 5 years

Required licenses or certifications:

  • ASQ Certified Quality Auditor
  • LeanSix Sigma Green Belt
  • Lean Manufacturing
  • ASQ Certified Quality Engineer

$80K