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Quality Assurance Operations Lead

Location

Charles City, IA, USA

Department

Quality Assurance

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At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!

Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.

Overview

The Quality Assurance Operations Lead will work to develop and maintain quality systems that support the daily manufacturing operations to meet product and process quality metrics.  They will act as an ambassador for World Class Manufacturing by working closely with operations team members, team leaders, technical support specialists and business unit leaders

Responsibilities

  • Complete area inspections prior to solids charging to vessels or heel removal from filters/dryers.
  • Perform equipment cleaning verification.
  • Participate in line clearances for product packaging.
  • Serve as plant floor support during normal processes.  Conduct internal audits – floor type walk throughs – with Superintendents/Production Supervisors/Operators on a routine basis.
  • Provide training on cGMPs and Quality Systems on a regular basis and as need is presented.
  • Act as an ambassador for World Class Manufacturing by working closely with operations team members, team leaders, technical support specialists and business unit leaders.

 

Responsibilities for Quality Systems administration and compliance support may include but are not limited to:

 

  • Assessment and approval of deviations, including risk/impact assessments.
  • Correct/Preventative Action (CAPA) plans.
  • Complete investigations of Out-of-Specification/Out-of-Trend (OOS/OOT) results and other non-conformances.
  • Monitor and trend Quality Systems.

 

Responsibilities for Lot Release may include but are not limited to:

 

  • Review of production records.
  • Review of in-process and release testing.
  • Disposition of product, in-process and raw materials.

 

All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures.  All employees are expected to report to work regularly and promptly.  Other duties relating to departmental mission, not specifically detailed in this section may be assigned.

Qualifications

  • Bachelor’s of Science degree in sciences (preferably Chemical Engineer, Chemistry or Biology)
  • 0-4 years’ experience in Quality Assurance is required
  • Working knowledge of quality systems, cGMP, FDA requirements and industry standards
  • Strong critical thinking skills
  • Strong interpersonal and leadership skills, including initiative and strong work ethic.
  • Experience at a commercial manufacturing facility for pharmaceuticals is strongly preferred.