Senior QA Associate I

Job 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.

The Quality Assurance Senior Associate – OSD Support is responsible for supporting daily operations and monitoring compliance of the Oral Solid Dose (OSD) Manufacturing Area.

Responsibilities:

• Act as QA OSD Support representative on special committees and teams.
• Deliver key business messages to superiors and/or peers in a timely manner.
• Develop metrics and other tools to measure QA OSD Support and/or systems. Understand departmental KPIs and their impact on site targets.
• Interact with OSD Manufacturing 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 manufacturing organizations.
• Review and approve SOPs, master production records, training plans, work orders, and controlled forms.
• Provide input for, review, and approval of technical protocols and reports, equipment, process, and cleaning documents authored by the validation.
• Review, approve, and oversee the change control process for minor change controls generated by the OSD Manufacturing Area, including amendments and extensions.
• Act as the QA Contact and QA Approver for OSD Manufacturing investigations, incidents, minor deviations, environmental excursions, and executed CAPA.
• 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.

Qualifications:

• Bachelor's degree in a scientific discipline strongly desired
• Minimum 5-8 years' related experience in a Quality Assurance role in the pharmaceutical industry
• Capable of identifying solutions and following through to implementation
• Excellent communication and documentation skills. Communicates well in team settings. Seeks to understand others with diverse view points and expertise. Builds strong relationships with stakeholders external to QA and takes advantage of these relationships to identify new opportunities.
• Possesses the skills necessary to provide effective training/mentorship.
• Familiarization with oral solid dose manufacturing qualification and quality.
• Possesses a good understanding of current quality control and quality assurance GMP regulations.
• Demonstrates ability to generate and critique high quality/quantity of results from the QA team and present them coherently to an internal and/or external audience.