Danaher Corporation Quality Assurance Specialist in Fajardo Pll, Puerto Rico
Danaher Company Description
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 visitwww.pall.com/green.
Biopharm POR (Product Occurrence Resolution) coordination and handling for external customers in the Western Hemisphere. WH and global Biopharm POR monitoring for trends. Communication of critical trends to Management. Participation in Internal Audit Program. Development of a strong relationship with strategic / key customers and a thorough knowledge of the Pall BioPharmaceuticals market, as well as customer expectations.
* Complies with legal requirements by adherence to requirements of existing and new regulations and legislation.
* Complies with all company policies and procedures.
* Must be a team player.
* Must be customer and results oriented.
* Ensures a safe and healthy environment by complying with all company safety policies and procedures.
* Coordinates Biopharm PORs (Product Occurrence Resolutions) for external customers in the Western Hemisphere:
* Tracks progress and status, expedites closure of POR investigations.
* Utilizes POR database to manage / document pertinent investigation files; coordinates all customer complaint investigation efforts.
* Follows up with sales / distributor personnel on issues related to PORs.
* Coordinates / expedites the receipt and evaluation of complaint sample by SLS, manufacturing facility or Product Engineering/R&D.
* Prepares quality response letters (interim status and final communications, by summarizing POR investigation results) to customers.
* Prepares additional quality-related communications, as requested by customers.
* Ensures that the communication to customer contains relevant, accurate technical information and meets customer needs, as well as adheres to internal requirements.
* Ensures that required cycle times are consistently met for POR closures, as per internal procedures and customer requirements.
* Coordinates POR-related CAPA activities:
* Monitors, tracks and ensures harmonization of critical CAPAs across all manufacturing sites.
* Ensures appropriate actions are taken to correct root cause of complaint-related issues.
* Ensures target dates are met for completion of corrective actions.
* Monitors effectiveness of actions taken.
* Communicates CAPA updates to customers, as needed.
* Monitors global and Western Hemisphere Biopharm PORs for trends:
* Provides weekly status reports on POR trends to Management.
* Provides WH and global POR trending data on critical quality issues for: Quarterly Global Biopharm Quality meetings, Periodic MRP meetings, Pall Sales / Marketing.
* Provides customer-specific trending, as part of periodic quality reviews with strategic customers.
* Participates in Pall’s Internal Quality Audit Program, as needed.
* Coordinates Product Recalls / Customer Notifications: * Maintains and tracks proper documentation of all recall activities. * Assures reconciliation of returned product for appropriate closures
Additional Functions: * Participates in other quality assurance functions / projects, as related to the management of quality systems. * Ensures continuous personal development; including up-to-date training on all LS Policies, pertinent SOPs; general cGMP and product training, FDA, Regulatory / Industry guidelines, as needed. * Travel requirements (<10%) * Develops knowledge of Pall BioPharmaceuticals market, customer expectations, customer base and product strengths and weaknesses by visiting customers for initial understanding of market and eventually on quality related issues and / or attendance at on-site customer meetings, as Biopharm POR (Product Occurrence Resolution) coordination and handling for external customers in the Western Hemisphere. * WH and global Biopharm POR monitoring for trends. * Communication of critical trends to Management. * Participation in Internal Audit Program. * Development of a strong relationship with strategic / key customers and a thorough knowledge of the Pall BioPharmaceuticals market, as well as customer expectations.
- Bachelor's Degree in a scientific discipline
- 5 years relevant experience, as specified above
- Fully bi-lingual - verbal and written
- Ability to interpret data and technical reports / documents
- Knowledge of computer and computer software (Excel, PowerPoint, Lotus Notes, SmartSolve, SAP), as well as trending and analytical skills. Preferred Qualifications:
- Background or certification in Quality Assurance (Quality Systems / cGMP, internal audits) and in pharmaceutical-related, FDA-regulated, industry.
- Excellent written and verbal communication skills.
- Strong analytical and problem solving skills (must be able to analyze trends).
- Must display tact, diplomacy and professionalism in difficult situations.
- Excellent organizational skills, with ability to multitask and work in a high pressure, as well as dynamic environment.
- Must deal effectively with management and staff in areas within Pall Corporation and outside the organization.
- Must protect the confidentiality of sensitive information within the QA department and within Pall Corporation.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.
- Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
- Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio and percent and to draw and interpret bar graphs.
- Ability to apply sound judgement understanding to carry out instructions furnished in written, oral or diagram form.
- Ability to deal with problems involving several concrete variables in standardized situations.
Pall Corporation is an Equal Opportunity Employer who encourages diversity in the workplace. All qualified applicants will receive consideration for employment without regard to gender, race, color, national origin, ancestry, citizenship, religion, age, physical or mental disability, medical condition, sexual orientation, gender identity or gender expression, military or protected veteran status or marital status.
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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% 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.
Job Function: Quality and Regulatory Affairs
Primary Location: North America-North America-United States-PR-Fajardo Pll
Req ID: LIF003841