Détails du poste

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POSITION:                Quality Control Senior Associate - Laboratory

DEPARTMENT:        Quality
LEVEL:                       P2
LOCATION:               Cork, Ireland

PURPOSE OF THE ROLE

The Quality Control Senior Associate is responsible to support a range of Quality Control (QC) activities, including product oversight, quality event reporting, investigations, stability programs and new product launch activities across a diverse portfolio of US and Canadian regulated products within McKesson’s Private Label business. Operating under direct supervision, the role ensures day to day compliance with standard operating procedures and regulatory requirements while contributing to continuous improvement initiatives essential to maintaining McKesson’s commitment to excellence in Quality.

KEY RESPONSIBILITIES

• Product Quality Control
  • Complete routine identification testing by HPLC, FT-IR, UV-VIS, to verify product quality against established specifications using Agilent OpenLab CDS system.
  • Conduct peer reviews of HPLC pre-run checklists to ensure compliant sample and instrument preparation
  • Log incoming samples for Finished Product testing
  • Assist in the preparation of in-house product specifications for routine testing, ensuring accuracy and alignment relevant validation documentation and route for approval through the electronic Quality Management System (eQMS)
  • Support HPLC, FT-IR, UV-VIS analytical method development for Laboratory testing 
  • Draft method development and validation protocols to support analytical testing
  • Liaise with suppliers procuring product samples for HPLC development activities
  • Review USP Pharmacopeia to determine suitability of product for testing
  • Track and log Stability test results for re-packaged product using eSTAR software application
  • Draft annual stability schedules to ensure visibility for compliance monitoring.

• Quality Risk Management
  • Document non-conformances, CAPA and change controls within the eQMS
  • Draft field alert reports (FAR) for FDA submissions
  • Participate in investigations related to out-of-specification (OOS) results, deviations, or other quality issues and implement robust corrective and preventative actions and ensure timely closure of Quality events.
  • Participate in the preparation of risk assessments proposing proactive solutions to mitigate quality and supply chain risks

• Cross-functional & Operational Support
  • Support Good Laboratory Practices maintaining in-house and external quality standards
  • Support general maintenance including procurement of laboratory consumables to ensure uninterrupted Laboratory operations
  • Assist in generating QC reports, metrics, dashboards, scorecards, and compliance data
  • Participate in continuous improvement initiatives including digital transformation and automation in Quality workstreams
  • Support the New Product Launch (NPL) process, consulting with internal departments and external suppliers on product Quality related activities

(The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties.)

REQUIREMENTS

Education/Experience:

• Batchelors degree or higher in Chemistry, Microbiology or other scientific discipline.
• Minimum of 2+ years pharmaceutical or medical device industry experience

Skills and Competencies:

• Strong problem-solving and critical thinking abilities; able to make sound judgments within defined procedures 
• Demonstrated technical writing ability in authoring quality events, change control, CAPA and standard operating procedures  
• Solid understanding of cGMP and regulatory principles in a finished dose pharmaceutical laboratory environment
• Proven knowledge of HPLC method development and validation techniques
• Understanding of Finished Product manufacturing and testing requirements of multiple dosage forms
• Proven analytical skills and ability to transfer findings into technical reports and presentation formats
• Ability to work effectively with others to accomplish goals in a challenging environment.
• Effective written and verbal communication skills, with the ability to work collaboratively across teams 
• Demonstrated commitment to learning, accuracy, and compliance in a regulated industry
• High attention to detail with a structured, methodical, and process-driven work approach
• Adaptable and receptive to evolving regulations, priorities, and technologies in a dynamic environment 

Technical Proficiency:

• Proven knowledge of HPLC method development and validation techniques
• Solid understanding and knowledge of cGMP and regulatory principles in FDA manufacturing environments
• Working knowledge of an electronic quality management system, such as MasterControl
• Proficient in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook, Teams)
• Comfortable working with quality documentation databases and digital collaboration platforms.

Work Environment/Physical Demands:

• Laboratory and general office environment.

At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to supportphysical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves.

As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations.In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

Our Base Pay Range for this position

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McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.

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