Analytical Quality Assurance Specialist

The Analytical Quality Assurance Specialist will be the primary point of contact for a given product/program. This position is expected to support multiple programs as needed and support the coordination of the quality systems. Work is highly independent.

• Ensuring that adequate QA support is provided for cross functional internal meetings and Customer teleconferences
• Communicating the status of QA related items to internal Teams including material/batch release and investigation status
• Taking an active role providing, as appropriate, guidance within the approved systems and procedures as it relates to GMP analysis and release of materials/products; some of this guidance may be required outside of the typical working schedule (off shift)
• Taking an active role in planning and execution of action items related to support of analysis and product release, including analytical data review activities and review of associated reports
• Managing the release of results and materials/products to customer within the approved systems and procedures. Managing change controls in support of analytical and release activities
• Review and/or conduct investigations for deviations in production and testing (VAR, MNCRs, OOS/OOT investigations, QCRs) within required timelines.
• Ensuring validation and qualification requirements are established in approved protocols and results of the validation and qualifications are adequately presented in approved reports
• Responsible for facility/laboratory audits of the respective areas periodically.
• Review of analytical data to confirm accuracy, data integrity, completeness, and appropriateness for use in release of analytical results.
• Management of document control for analytical facility.

Education and Experience

• Bachelors degree in an appropriate science. Masters Preferred.
• 10-14 years of related technical experience or equivalent combination of education and experience.
• Experience with performing and participating in root cause analysis related to investigations, deviations, and audit findings
• Experience with assessing departures from procedures and assigning appropriate CAPAs and assessing effectiveness of changes and CAPAs.
• Experience with analytical testing and/or analytical method development required.
• Management experience preferred

Competencies/Skills

• Strong attention to detail.
• Ability to work in a face paced, team-oriented environment.
• Ability to act with a sense of urgency, while maintaining accuracy and data integrity.

Working Conditions

Participates in production support including nights, weekends, and holidays.

This role may involve work in laboratory or manufacturing environments with potential exposure to chemicals or other regulated substances. As a condition of employment, incumbents may be required to participate in employer-provided medical surveillance programs in accordance with applicable regulatory requirements and company policy.