Quality Lab Specialist PPP

About the role

Overall responsible for all activities within PPP NA (Gx Berlin, Ohio)

Responsibilities

• Perform visual and dimensional inspections (microscope and gauge).
• Start-up / daily samples.
• Describe evaluation and decisions about approval or reject products.
• Consult and record information in the Systems (Event log, SAP, etc).
• Perform equipment calibration before measure samples.
• Create, review and approve documentation in D4.
• Support in developing the Quality System Management.
• Archive paperwork in accordance to quality checks and inspections per the Control Plan, Batch release and Validation process.
• Collect, document and ship PDS/TGS samples for customer.
• Pack and label finished products according to the Control Plan.
• Prepare new order documentation for production and quality.
• Release batch of finishes goods.
• Release or reprove incoming goods.
• Release or block skids.
• Check the humidity, temperature and pressure of cleanroom.
• Organization and cleanliness (6S).
• Open CAPA and Deviation.
• Responsible for conducting root cause investigation meeting and manager of the action.
• Perform the delimitation process and inspect the materials for defects.
• Conduct internal trainings.
• Maintain 6S environment in work area, and ability to lift up to 56 pounds, and move 200 pounds.
• Monitor services provided by third parties.
• Responsible for schedule and approval documents from cleanroom monitoring, equipment calibration and other external services.
• Perform Internal Audits.
• Provide support in Internal and External Audits.
• Open Change Request and Prepare Validation Reports.
• Follow Good Manufacturing Practices (GMP), Good Documentation Practices and Values TRIBE.
• Provide support to other areas regarding any questions related to compliance with ISO Standards, customer requirements and internal procedures.
• May assist in other areas or perform other duties as required by fluctuating business needs.

Qualifications

• Academic background.
• Knowledge in quality tools (control charts, 5S, Ishikawa diagram, 5 why).
• Knowledge of metrology (measurements results, tolerances, microscope).
• Knowledge Office package (e-mail, word, excel, power point).
• Knowledge in Quality Management System.
• Knowledge of ISO 9001 and internal Audits.
• Possesses well-developed communication and interpersonal skills.
• Possesses / acquires mobile equipment license.
• Ability to work in a high paced and multi-task environment.
• Maintains positive team environment.
• Ability to read, write and follow written or verbal instructions.
• Ability to speak, read and write English.
• Possesses basic math skills.
• Understands basic quality inspection process.
• Self-motivated and able to work with minimal supervision.

Gerresheimer/Centor is an Equal Opportunity Employer