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