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Quality Technician - Lead Internal Auditor


  • DonLevy Laboratories
  • 02/18/19
  • Crown Point, IN
  • 46307
  • dep on exp / Yearly
  • Full-Time
DonLevy Laboratories is an independent, commercial, food testing laboratory dedicated to food safety and committed to quality challenges throughout the supply chain. We perform microbiological and chemistry analyses on environmental, raw material, and finished product samples submitted by food companies industry wide.

In addition to routine microbiological testing, DonLevy Laboratories provides on-site microbiological assessments and sanitation audits, customized shelf life evaluations, individually designed challenge studies, and training for our clients.

General Function:
To assist the Quality Manager by performing support functions.

Characteristic Duties and Responsibilities:
1) Responsible for training of new internal auditors
2) Responsible for internal audit activities
a. Quarterly Internal Audits
i. Maintains internal audit plan, including dates of assessments
ii. Maintains audit checklist used during internal audits
iii. Conducts quarterly audits as specified in quarterly audit schedule
iv. Conducts pre-audit meeting with audit team
v. Conducts quarterly audit opening and closing meetings with members of management
vi. Consolidates all internal auditor findings and observations and prepares quarterly audit report
vii. Presents quarterly audit findings and non-conformities to members of management
viii. Provides audit results and non-conformities to auditees
ix. Follows up on action items identified during quarterly audit
b. Internal Team Audits (outside of audit plan)
i. Conducts monthly meetings of the internal audit team
ii. Conducts internal audit team audits as necessary
1. Consolidates all internal auditor findings and observations and prepares internal audit report
2. Presents internal audit report findings, observations, and non-conformities to Quality Manager
3. Interacts with departmental supervisors and managers to address internal audit findings, observations, and non-conformities
4. Follows up on action items identified during internal audit
c. Self-Improvement Assessments (SIA)
i. Ensures monthly SIA are completed and submitted by Internal Auditors
ii. Reviews SIA performed by internal audit team members and provides summary of findings, observations, and non-conformities to members of management
iii. Follows up on action items identified during SIA
3) Monitor laboratory quality assurance programs to ensure compliance and continuous improvement
4) Assist Quality Manager with development and implementation of new quality programs as necessary
5) Monitor internal quality systems and inform Quality Manager of compliance gaps and
devise corrective actions as needed
6) Review general laboratory documents as needed during performance of audits or follow up of a preventative or corrective action
7) Monitor completeness of +/- control book and incubation documents throughout the week; report findings to Quality Manager
8) Maintain GLPs (Good Laboratory Practices) and ensure compliance
9) Monitor customer complaints (COMPLAINTS), procedural deviations (PROCDEV), internal non-conforming quality control reports (INQC), and preventative action requests (PAR) and discuss with Quality Manager as necessary
10) Assist Quality Manager in maintaining Vendor/Supplier Self-Questionnaires
11) Assist Quality Manager in Regulatory and Compliance updates
12) Assist Quality Manager in FSMA compliance, including preparation for laboratory registration
13) Additional duties as assigned

Minimum Requirements:
Bachelors degree in Biology or Microbiology, minimum of two years microbiology laboratory experience, or equivalent combination of education and experience.

Knowledge, Skills, Abilities and Desirable Traits:
Excellent organizational skills and attention to detail; the ability to work independently with minimal supervision; proven decision making capabilities; strong sense of urgency and accountability; ability to successfully work through conflict; desire to be a productive team member who exhibits until the job is done behavior.

Working Conditions:
Physical effort usually requires considerable walking and standing with some lifting. Some exposure to unpleasant elements. Some element of personal risk due to handling of bacteria, chemicals, steam and heat.

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