Senior Quality Assurance Specialist

2 days ago


Petersburg, United States Civica Rx Full time
About this Role
Civica Rx is seeking an experienced Senior Quality Assurance Specialist to support quality systems and oversight for product process validation, cleaning validation, Quality Risk Management, and quality laboratory systems that meet cGMP and Civica compliance requirements.

Key Responsibilities
Work with validation and engineering teams to provide quality oversight for validation and qualification activities.
Participate in Quality Risk Management and analysis.
Maintain current knowledge of local and international regulatory and legislative requirements and trends.
Support product process transfers, including validation, from and/or to other manufacturing sites.

Requirements and Qualifications
Bachelor's degree in a scientific discipline with 4+ years Quality/cGMP experience in the pharmaceutical industry.
Experience in process and cleaning validation, LIMS systems, Aseptic Process Simulations, and Quality Risk Management.
Knowledge in 21CFR Part 11, Electronic Records and Signatures, and data integrity is required.

Payscale
The estimated salary range for this position is $90,000 - $120,000 per year.

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