Sr Quality Assurance Specialist

Evonik•Birmingham, AL

About The Position

This position is responsible for providing quality and technical support to the production team providing oversight to manufacturing rooms and laboratories by reviewing and approving data and all other Quality Management System documentation. The position utilizes risk management, quality planning and statistical analysis to complete assigned tasks..

Requirements

Bachelor of Science degree in Chemistry, Biology, or Engineering.
Minimum eight years’ experience in pharmaceutical or medical device manufacturing, preferred.
Minimum five years’ experience in a pharmaceutical or medical device Quality Assurance role preferred.
Proficient computer skills, Microsoft Word, Excel, Access.
High attention to detail, organization, and accuracy
Strong written and verbal communication skills.
Good interpersonal skills.
Knowledge of FDA’s cGMP and/or QSR quality system requirements.
Comprehensive technical skills/knowledge
Applied statistics experience, preferred.
Validation experience, including process validation
Advanced analytical and problem-solving skills
Experience in Regulatory Agency inspections.
Experience in aseptic techniques and manufacturing.

Responsibilities

Represent quality department on development project teams.
Review and approve product and process-related documentation.
Support the generation and justification of product and materials specifications.
Provide support for the development of validation strategies and validation plans.
Review/approve protocols and reports.
Support Deviation / CAPA investigations.
Support interdisciplinary teams for root cause analysis of quality deficits using known of problem-solving tools.
Support product quality and System improvements activities.
Support collection and analyze data to identify opportunities for quality improvement.
Work with multifunctional teams (R&D, Manufacturing, Operational Compliance, and Engineering to drive resolution to product complaints.
Support to facilitate risk assessment activities such as design and process FMEA.
Ensure product risks are identified, and risk mitigation controls are put in place to eliminate product risk to an acceptable level.
Provide real time production floor QA oversight.
Evaluate manufacturing data for trends and other special causes.
Review and disposition manufacturing / packaging batch documentation.
Perform room / line clearances as needed.
Review and disposition raw materials / components for manufacturing.
Support resolution of quality issues in manufacturing.