Complaint Handling

• Work with multifunctional teams (R&D, Manufacturing, Operational Compliance, and Engineering to drive resolution to product complaints

Verification, Validation and Qualification

• Provide support for the development of validation strategies and validation plans

• Review / approve protocols and reports

o Design verification

o Process validation

o Cleaning validation

o Facility/cleanroom validation

o Equipment qualification

JOB DESCRIPTION SUMMARY

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.

PRINCIPAL ACCOUNTABILITIES

Routine Quality Assurance functions, to include but not limited to:

Manufacturing Support

• Provide real time production floor QA oversite
• 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

Product and Process Development

• 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

Deviations/ CAPA

• Support Deviation / CAPA investigations

• Support interdisciplinary teams for root cause analysis of quality deficits using known of problem solving tools
• Failure reports for products in the field
• Identification of potential failure modes and risks
• Resolving of customer issues appropriately

Continuous Improvement

• Support product quality and System improvements activities
• Support collection and analyze data to identify opportunities for quality improvement

Complaint Handling

• Work with multifunctional teams (R&D, Manufacturing, Operational Compliance, and Engineering to drive resolution to product complaints

Risk Management

• 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

Verification, Validation and Qualification

• Provide support for the development of validation strategies and validation plans
• Review / approve protocols and reports

• Design verification
• Process validation
• Cleaning validation
• Facility/cleanroom validation
• Equipment qualification

REQUIREMENTS

• Bachelor of Science degree in Chemistry, Biology, or Engineering , preferred.
• Minimum two to three years’ experience in pharmaceutical or medical device manufacturing
• Minimum two to three years’ experience in a pharmaceutical or medical device Quality Assurance role
• Proficient computer skills, Microsoft Word, Excel, Access
• High attention to detail, organization, and accuracy
• Strong written and verbal communication skills
• Good interpersonal skills
• Knowledge or understanding of FDA’s cGMP and / or QSR quality system requirements
• Experience in Regulatory Agency inspections , preferred
• Experience in aseptic techniques and manufacturing , preferred.

Your Application

To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal . Further information about Evonik as Employer can be found at https://careers.evonik.com .

Please address your application to the Talent Acquisition Manager, statingyour earliest possible starting date and your salary expectations.

Your Talent Acquisition Manager:
Vincent Szewczyk [C]

Company is
Evonik Corporation