Company Summary: Centor is a Gerresheimer company. Centor/Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as solutions for the health industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, ampoules, tablet containers, infusion, dropper and syrup bottles and more. Centor/Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With 35 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. With around 12,000 employees, the company generated revenues of around €2bn in 2023. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).
Job Description: Quality Lab Specialist PPP NA, Gx Berlin, Ohio
Main tasks
- Under the direction of the Quality Manager, the Quality Specialist should be able to perform all Quality Technician activities and ensure compliance with ISO Standards, customer requirements and internal procedures.
- Provide support to develop and maintain the quality management system, be responsible for batch releasing or blocking, conduct internal audits, provide internal training to employees on compliance with ISO procedures and internal procedures, monitor third-party activities, promote continuous improvement and prepare validation reports.
- Use the TRIBE Values (Team, Responsibility, Integrity, Bold Innovation and Excellence).
Area of responsibility
- Overall responsible for all activities within PPP NA (Gx Berlin, Ohio)
Quality Specialist:
- 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.
- 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.
Safety & Compliance:
- Actively communicates with coworkers – key items within the plant environment on safety, quality, maintenance, production and continuous improvement.
- Maintains 6S environment in work area, and ability to lift up to 56 pounds, and move 200 pounds.
- Adheres to plant and corporate safety policies.
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 and affords equal opportunity to all applicants and employees for all positions without regards to race, color, religion, sex national origin, age, disability, veteran status, or any other legally protected status in accordance with applicable federal, state, and local laws.
