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Senior Technical Specialist, Quality Assurance in Portsmouth, United Kingdom at Pall

Date Posted: 6/12/2019

Job Snapshot

Job Description

Job ID: PAL003288

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 https://www.pall.com/en/about-pall.html.


Description

Position Objective: 


To provide quality assurance support to the European SLS Validation and Laboratory Operations, and Process Development Services teams.

Role and Duties:


• Supports the development and implementation of local quality practices and activities within SLS to assure continuous improvement, and integration of SLS activities within QMS requirements in ISO9001 certified Pall locations. Works with teams to aligns Pall SLS services team’s quality processes with customer expectations, industry guidelines and regulatory standards as applicable.

• Perform Quality review and release of local SLS procedures, as applicable, and direct the activities of the Document Coordinator with respect to updates and maintenance of local quality documents and records.

• Awareness of pharmaceutical regulatory requirements (USFDA/EMA/ICH), compendial standards (USP/EP/ISO) and other standards (ASTM) related to Biotech Validation/Laboratory activities

• Monitoring of local customer or third-party audits of the local QMS. Participate in the development of action plans to address external findings and observations. Participate in internal and external quality audits as required.

• Hosting of customer audits including planning, and response. Hosting audit action follow-up reviews.

• Champion continuous improvement efforts and defect reduction initiatives to establish and maintain an effective Quality Management System (QMS). 

• Perform root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements. Assure that local SLS non-conformances (NCRs) are properly recorded and investigated and that necessary corrective actions are taken, as appropriate. Assist local teams to ensure that effective RCCM is performed across the V&LO and PDS organizations.

• Report to SLS/BU Senior Management team on quality issues, trends through periodic Quality Reviews for both V&LO and PDS processes.

• Educate and train employees as to their impact in the quality management system.

• Assist in the implementation of SLS best practice in the areas of test methods verification and validation, equipment calibration, preventive maintenance, risk assessment, and change control meet all applicable quality and regulatory standards, customer, and Pall Corporation requirements.

• Support the resolution of customer complaints related to SLS services.

• Provide metrics (process capability, control charts, measurement quality) for monitoring performance within SLS to assure goals and objectives are being met, and to enable managers to make sound performance improvement decisions.

• Interact with internal and external customers to identify opportunities to establish, develop and expand effective customer feedback tools within SLS locally, and regionally.  Collect customer feedback and perform trend analysis.

Job Requirements



Qualifications

• Bachelor’s degree in a Scientific or Engineering discipline.
• Background in QA or experience in a regulated industry. 
• Extensive experience in Biotech/QA/Scientific industry.
• ISO 9001 internal and or lead auditor is desirable.

Position Competencies:
• Contributes to the development of functional/operational strategy.
• Supports the resolution of complex quality or operational problems through critical thinking.
• Appropriate experience in functional areas to which support is being provided.
• Ability to accurately assess key business metrics.
• Sound training, consulting and influencing skills.
• Demonstrated proficiency in time and project management.
• Teamwork - must be able to affect team performance.
• Hands-on and detail-oriented.
• Strong customer focus.  
• Independent worker.  
• Communication—must be able to effectively communicate in both written and verbal forms, throughout the organization.
• Excellent interpersonal skills 
• Self-starter and self-motivated

Other Requirements:
• Effective decision making and analytical ability to make sound decisions and recommendations after receiving related data, circumstances, options and consequences.
• Strong problem-solving skills
• Works under consultative direction toward goals and objectives. 
• Has a high level of Integrity and complies with all relevant company policies and procedures.
• Prepared to undertake limited international travel.
• To work safely and to comply with the company’s health, safety and environmental (HSE) policies and procedures.




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 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 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.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.