Quality Assurance Specialist

Description:

Lead and oversee the Quality Investigations (Laboratory / Manufacturing Investigations and deviations)

Author and/or participate in Lab and Manufacturing related deviations, OOS investigations and Quality events.

Lead and/or participate in the implementation of meaningful and effective corrective actions for deviations, OOS investigations and lab events.

Work with the QC Review and Document Control teams to ensure all laboratory testing and support documentation is reviewed, closed out and archived within appropriate timeframes per established procedures.

Represent QC Compliance in cross-functional meetings regarding inspection readiness, deviations, CAPAs and change controls.

Track, monitor and report on compliance related metrics in various forums, including presentations to key leadership and stakeholders.

Perform various document reviews as the Compliance stakeholder, as assigned.

Accept, complete, and report on special assignments within the agreed upon timeframe as assigned.

Additional Skills & Qualifications:

Minimum 5-8+ years of QC and/or QA experience in a pharmaceutical cGMP setting.

B.S. degree in relevant scientific discipline.

Excellent technical writing skills and experience authoring deviations, investigations, and procedures in a cGMP setting.

Knowledge of relevant and current FDA, ICH guidelines and regulations.

Excellent ability to communicate in a scientifically sound and understandable manner.

Demonstrated ability to prioritize, manage and complete multiple projects and tasks in a fast-paced environment effectively and independently.

Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

Ability to navigate through ambiguity and rapid growth and adapt to change.

Preferred Qualifications: -

MS in a relevant scientific discipline with 2-5+ years QC and/or QA experience in a pharmaceutical cGMP setting.

Previous experience in a laboratory compliance function within QC or QA.