Senior Quality Assurance Associate

3 weeks ago

Cincinnati, United States CareerBuilder Full time

Our client, a global pharmaceutical company, is looking to add a Senior QA Associate I/II to their team in Ohio. This position is responsible for supporting daily manufacturing and facility operations along with project support. Functions include proactive support of change control assessments, documentation reviews and validation review/support.

Responsibilities:
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.
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.
Act as an internal auditor, leading audit when necessary.

Requirements:
Bachelors degree in a scientific discipline or equivalent
Minimum of 5 - 8 years experience in a Quality Assurance role in the pharmaceutical industry.
Experience in complex criteria investigations, quality control or lab investigation experience required
Audit or other professional quality certification or equivalent experience preferred.

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