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Sr. Quality Assurance Specialist

Location

Durham, NC, 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, STD, 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

Support Quality System Management Review planning and review process.

Responsibilities

  • Coordinate and review tracking of Deviations, Change Controls, CAPAs and OOS events for the site.
  • Review and approval of GxP laboratory test records, deviations, change controls, corrective and preventive actions (CAPA) and specifications. 
  • Prepare, maintain and analyze metrics related to the quality systems.
  • Support the quality team to achieve quality goals and metrics.
  • Support Internal, Supplier and Client audits.
  • Lead project improvement projects as needed and assigned in a cross functional group.
  • Review and approve documents in an electronic document management system.
  • Communicate effectively with internal personnel, as well as external customers (if applicable).
  • Review and approve stability protocols.   Review stability data at respective timepoints for compliance, trends, and out-of-specifications.

Qualifications

  • BS or BA Degree with 5+ years, MS Degree with 2+ years, working in a Biotech or Pharmaceutical FDA regulated industry.
  • Experience leading CAPA and Deviation Management to closure.
  • Prior experience conducting internal and supplier audits.
  • Prior experience maintaining pharmaceutical quality systems.
  • Experience with and working knowledge of CGMP and GLP quality systems, policies and regulations/guidelines.
  • Ability to influence others for the better of the company.
  • Participate in developing department goals, objectives, and systems.
  • Exceptional analytical and problem-solving skills with the proven ability to think strategically.
  • Highly effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines.
  • Ability to influence employees in a matrix organization to ensure completion to pre-established due dates.
  • Excellent diplomatic, analytical, and communication skills – both verbal and written.