Company Summary: Centor/Gerresheimer is an innovative system 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).
Quality Lab Technician PPP NA - 2nd shift 3pm - 11pm
Main tasks
- Under the direction of the Quality Manager, the Quality Technician should monitor and inspect the products according to customer specification, performing test and measures, filling out the reports ensuring the integrity of the information, approve or reject products, identification and reporting of non-conformities, compliance with GMP (Good Manufacture Practices), the safety standards and use of PPE. Release batches of finished goods and incoming good, perform delimitation and inspections in products and conducts internal audit.
- Ensure compliance with ISO Standards, customer requirements and internal procedures.
- Use the TRIBE Values (Team, Responsibility, Integrity, Bold Innovation and Excellence).
Area of responsibility
Quality Control:
- 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.
- Archive paperwork in accordance to quality checks and inspections per the Control Plan, Batch release and Validation process.
- Consult D4 to access procedures and forms.
- Collect, document and ship PDS/TGS samples for customer.
- Pack and label finished products according to the Control Plan.
- Release batch of finishes goods
- Release incoming goods.
- Release or block skids.
- Check the humidity, temperature and pressure of cleanroom.
- Organization and cleanliness (6S).
- Open CAPA and Deviation.
- Participate in root cause investigation meetings.
- Perform the delimitation process and inspect the materials for defects.
- Perform Internal Audits.
- Provide support in Internal and External Audits.
- 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 5S environment in work area, and ability to lift up to 56 pounds, and move 200 pounds.
- Adheres to plant and corporate safety policies.
Qualifications
- Attention to detail for visual inspection, measurements and procedures and forms documentation.
- Accuracy and quick feedback on inspection results.
- Basic knowledge of metrology (measurement results, tolerances, microscope).
- Basic knowledge of quality tools (control charts, 5S, Ishikawa diagram, 5 why)
- Basic intermediate Office package (e-mail, word, excel, power point).
- Basic knowledge of ISO 9001.
- 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.
$23.75/hr
$2.00/hr shift diff for off shifts
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.
