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Director of Quality Control

Insight Recruitment Omaha, NE
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Job Description

We are an established, global provider of high quality products for use in the Food and Pharmaceutical Industries.  It is our intention to employ the most qualified and experienced individuals to help our company enter into a new era of expansion in pharmaceutical manufacturing.  We are looking for a Director of Quality Control to join our growing team.  Salary: up to $175k plus bonus and benefits that simply do not exist at other companies.

In this new role, you will have the opportunity to leave your fingerprint on our organization by utilizing your skills and experience in pharmaceutical quality control to ensure that we are meeting all FDA regulations. You will be responsible for all operational aspects of the QC function for Solid Oral Dosage Drug Product, API, Food and Technical projects including, remediation and working closely with internal and external partners to ensure cGMP compliance. 

We need an experienced leader who is persuasive, and can lead a team into brand new areas that support our company’s long-term goals and success.

Responsibilities:

  • Provide Subject Matter expertise with internal and external clients and regulatory agencies on all QC matters.
  • Oversee all operational aspects of the Quality Control function for Solid Oral Dosage Drug Product, API, Food and Technical products.
  • Design, manage, plan, and direct the QC laboratories to ensure testing which provides the highest quality analytical support for manufacturing while ensuring compliance with protocols, cGMP and safety regulations.
  • Provide guidance on remediation projects.
  • Provide leadership, management, evaluation and training to all laboratory employees. This includes project management, method development and validation, raw data/protocol/report review, in-process and product release testing, stability programs, data trending, reference standards, external auditing, deviations, CAPAs, OOSs/OOTs).

Requirements:

  • Bachelor’s degree in a science related field.  Advanced degree preferred.
  • 10 years of pharmaceutical Quality experience.
  • Previous experience in designing & managing a pharmaceutical Quality Control department, in a cGMP environment, is required.
  • Remediation experience is required.
  • Lab start up experience is a plus.

This is a rare opportunity to make a direct and lasting impact on a growing company.  Join us now!

 

Job Details

Date Posted May 4, 2018
Date Closes June 3, 2018
Located In Omaha, NE
Job Type Full-time Employee
Compensation Salary, $165,000.00 - $185,000.00, Based on Experience
Experience Level Experienced (7-15 yrs. experience)
Hours 45 hours per week
Start Date Immediately
Positions Available 1
SOC Category 11-3051.01 Quality Control Systems Managers
Zipcode 68105
Name Shawn Mischnick
City, State and Zip Lincoln, NE 68516
Phone 402-730-2645

This job offers the following benefits

  • 401(k) Retirement Savings Plan
  • Dental
  • Medical
  • Bonus Plan

This job requires the following skills

  • Quality Control
  • Regulatory Compliance
  • Manufacturing - Quality Inspections
  • CAPA
  • GMP

This job is related other jobs in these career categories

At a Glance
Enjoy these benefits
  • 401(k) Retirement Savings Plan
  • Dental
  • Medical
  • Bonus Plan
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