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Manufacturing Quality Assurance Specialist

Location

Longmont, CO, USA

Department

ManufacturingQuality 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

The Manufacturing Quality Assurance Specialist is responsible for manufacturing operations support. This position will work directly with manufacturing, analytical, and other departments to ensure that products conform to quality standards and all applicable regulatory requirements.

Responsibilities

  • Provide Quality support for manufacturing operations.
  • Responsible for batch record issuance and review.
  • Coordinate  and facilitate Deviations, Change Controls, CAPAs and OOS events as related to manufacturing operations.
  • Review and approve validation protocols for manufacturing related equipment, facilities, and utilities.
  • Review and approve calibration and maintenance events.
  • Support the Quality team to achieve quality goals and metrics.
  • Communicate effectively with internal personnel, as well as external customers.

Qualifications

  • BS or BA Degree with 2-5+ years, MS Degree with 2+ years, working in a Biotech or Pharmaceutical FDA regulated industry.
  • Prior experience in a manufacturing quality assurance support role, preferably in oral solid dosage and drug substance manufacturing.
  • Prior experience maintaining pharmaceutical quality systems.
  • Experience, or understanding, with international guidance and their application to early to late stage pharmaceutical programs.
  • 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.