Senior Quality Assurance Specialist

9/29/20

Longmont, CO 80501

1057

FullTimeRegular

Position Title: Sr. Quality Assurance Specialist

DUTIES:

  • Support Quality System Management Review planning and review process.
  • 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.
  • Review and approve documents in the 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 2-5+ 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.

SUCCESS FACTORS:

  • 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.
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