Senior Quality Assurance Specialist
Longmont, CO 80501
Position Title: Sr. Quality Assurance Specialist
- 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.
- 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.
- 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.