Sr QA Associate I/II - Dayton, United States - Germer International

Description

This function is responsible for supporting the daily manufacturing and facility operations along with project support. Functions include proactive support of change control assessments, documentation reviews and validation review/support.

Functions also include reactive support of discrepancy identification and resolution on the floor, Investigation Team Support, TrackWise Deviations, and reporting operational metrics.

This function supports and communicates events to shift leadership daily and thresholds when they are outside of the area of responsibility.

Responsibilities:
Act as QA Operations representative on special committees and teams.

Lead specific aspects of a project and guide solutions for difficult problems identifying best solutions based on project requirements.

Actively participate and contribute to the QA mission and objectives.

Deliver key business messages to superiors and/or peers in a timely manner.

Understand departmental KPIs and their impact on site targets.

Interact with manufacturing and facility operations and support personnel to ensure cGMP compliance and provide general guidance and support.

In these interactions, act as an ambassador of quality and compliance, driving quality culture by actively mentoring or coaching within the QA and operations organizations.

Review and approve SOPs, training plans, work orders, and controlled forms.

Provide input for, review, and approve technical protocols and reports.

Review, approve, and oversee the change control process for change controls related to applicable site operations, including amendments and extensions.

Act as the QA Contact and QA Approver for deviation investigations, executed CAPA, and effectiveness checks.

Assist in the identification of discrepancies, ensure investigations are thorough, drive to root cause, and have appropriate CAPA in place.

Able to lead exercises in root causes analysis within areas of support or cross-functionally for complex issues. Act as an internal auditor, leading audit when necessary.


Education & Experience Requirements:
Sr. QA Associate I

Bachelor's degree in a scientific discipline or equivalent

Minimum of - 8 years' experience in a Quality Assurance role in the pharmaceutical industry.

Sr. QA Associate II

In addition to above, would have experience in complex critical investigations, quality control or lab investigation experience required versus preferred, audit or other professional quality certification or equivalent experience preferred.

#J-18808-Ljbffr