Quality Assurance Specialist (f/m) in Bad Kreuznach, Germany at Pall

Date Posted: 5/8/2018

Job Snapshot

Job Description

Job ID: GEN000360

About Us

Pall Corporation is a global leader in high-tech filtration, separation, and purification, serving the diverse needs of customers across the broad spectrum of life sciences and industry.



Pall Life Sciences provides cutting-edge products and services to meet the demanding needs of customers discovering, developing and producing biotech drugs, vaccines, cell therapies and classic pharmaceuticals. Pall offers advanced medical technologies, which are often a patient’s last line of defense from dangerous pathogens. Pall’s food and beverage products provide critical protection from contaminants during various manufacturing steps.



Pall Industrial serves a diverse range of customers in the microelectronics, aerospace, fuels, petrochemical, chemical, automotive, and power generation industries. Pall is a key supplier to the innovative and demanding semiconductor and consumer electronics industries, and provides filtration products used in critical applications on commercial and military aerospace vehicles. Pall products are key to the reliability of industrial equipment. Pall’s engineered solutions help municipal and industrial customers address mounting water quality, scarcity and demand issues, and help energy companies maximize production and develop commercially successful next generation fuels.



Headquartered in Port Washington, New York, Pall has offices and plants throughout the world.



To learn more about Pall, please visit www.pall.com/green.



Description

Summary:

Contribute administratively to standard tasks of the department and cooperate with internal and external parties. 
Maintain documented information in accordance with QMS and Corporate requirements.
Participate in continuous improvement activities at the BK site and within LFB QA organization
Follow GMP, GdocP and site certification standard requirements (e.g. hygiene, QMS, Environment)

Key Activities:

Process support/Quality Planning

Participate in the preparation and implementation of documentation specifying quality criteria, sampling instructions, test methods and release criteria for the products manufactured in the designated LOB(s) with respect to the relevant regulatory requirements and Product Claim Specification (PCS) documents.
Review manufacturing and QC documentation & data for QA product review and conduct product release procedures. 

Participate in the review of process and/or test deviations relevant to the products manufactured in the designated LOB(s). Initiate and monitor corrective measures as required. (e.g. suspension of delivery, obtaining of testing exceptions). 
Provide QA data to internal parties for the preparation of change control, technical documentation and customer information.

Audits

Participate in customer, external and internal audits related to the designated LOB and QA responsibilities.
Participate in CAPA generation and implementation associated with audit non-conformances or recommended actions for improvements.
Participate in internal audits to the requirements of the specified standard to support the site self-assessment programme, including effectivity checks of CAPA plans.
Participate in supplier Quality management activities, including providing quality data for supplier rating assessment and participation in supplier audit programme.
Support LF&B R&D and Product Engineering projects on site as the QA team member for designated LOB(s).

Complaints/CAPA/Continuous improvement

Coordinate the investigation of customer complaints and support the manufacturing and QC root cause analysis, CAPA planning and reporting using complaint management software.
Support trend analysis review using complaint data, and participate in Problem Solving Process (PSP) to resolve adverse trends and KPI performance.
Participate in CAPA generation following inspection of internally rejected components and products, interpret statistical data, identify and implement corrective actions and continuous improvement for designated LOB(s)
Prepare input data for the CAPA review meeting for designated LOB(s) (all CAPA sources) and document the outcomes & actions from the meeting.
Participate in supplier Quality management activities and associated investigations relating to deviations with incoming products to the designated LOB(s).

Job Requirements



Qualifications

Qualification and Experience
  • State certified technician
  • Up to 5 years of experience in the field of QA and its related systems
  • Pilgrim/Smartsolve 
  • Knowledge of ISO 9001:2015, GMP and relevant standards
  • Audit training
  • Knowledge of BK products and manufacturing processes
  • Fluent in English and German


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.