McKesson

Sr Associate Quality Engineer

McKesson$65K — $109K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Degree or equivalent with 2+ years of relevant experience.
  • 3-5 years in a pharmaceutical quality/regulatory environment preferred.
  • Experience with Quality Management Systems and document control preferred.
  • Knowledge of pharmaceutical regulations, particularly FDA requirements, preferred.
  • Strong written and oral communication skills.
  • Detail-oriented with proficiency in MS Office programs.

Responsibilities

  • Oversee Corrective Action/Preventive Action (CAPA) program and ensure non-conformance documentation is complete.
  • Assist with Non-conformance Investigations and ensure timely closure of CAPA records.
  • Generate and analyze status reports from quality management applications to identify trends for improvement.
  • Lead repackaging and relabeling projects, coordinating with clients and creating necessary protocols.
  • Manage special client project requests and client complaint memos.
  • Back up for inspection and release process of products, including documentation and communication with clients.
  • Assist with client and regulatory activities and quality-related training as directed.

Benefits

  • Comprehensive health benefits package.
  • Employee wellness program.
  • 401(k) with company match.
  • Flexible work hours.
  • Professional development opportunities.
Full Job Description

The Senior Associate Quality Engineer is responsible for advanced quality oversight across daily operations, incident management, investigations, and client-facing quality activities.  This position partners with Operations, Account Management, and internal/external customers to act as a quality liaison to drive risk-based decision making, identifies emerging quality risks, and contributes to continuous improvement initiatives to strengthen compliance and process efficiency. 

Key Responsibilities  

  • Responsible for the oversight of the Corrective Action/Preventive Action (“CAPA”) program for their area of responsibility including but not limited to review all non-conformances to ensure they are documented, review all corrective/preventive actions for completeness, and execute effectiveness checks when required. 

  • Assist with Non-conformance Investigations assigned to Quality Assurance, as needed. Responsible for ensuring timely closure of CAPA records. 

  • Responsible for generating status reports from applicable QMS applications, analyzing data to identify potential trends and areas for improvement, and maintaining related company measurements. 

  • Responsible for repackaging and relabeling projects in support of client requests, as Project Leader. Including, but not limited to, communication with client and Program Manager regarding project details, pricing proposals for project, creation of the project protocol, inspection of the project as required by project protocol, and filing any necessary paperwork with client, Program Manager, and/or regulators. 

  • Manages all special client project requests, client complaint memos, and other relevant client memos. 

  • Serves as a back-up for the Associate Quality Engineer to perform the inspection and release process for incoming and returned product including but not limited to: downloading and review of temperature device data, communicating results to clients, obtaining proper client approval, electronic storage of inspection records, and product retains. 

  • Assists as needed with Client and Regulatory activities, Quality-related training, validation of storage areas/systems/equipment where required, and other duties and responsibilities as assigned by manager. 

Shift: 

11:00AM – 7:30pm THIS ROLE REQUIRES YOU TO BE ON SITE 5 DAYS A WEEK.  

 

Minimum Job Qualifications: 

Degree or equivalent and typically requires 2+ years of relevant experience. 

 

Critical Skills: 

  • 3-5 years in a pharmaceutical quality/regulatory environment, preferred 

  • Quality Management System and/or Document control management experience, preferred. 

  • Knowledge of pharmaceutical regulations, including FDA requirements, preferred. 

 

Preferred Skills: 

  • Ability to express ideas clearly both in written and oral communications.  

  • Ability to enter data accurately.  

  • Ability to handle multiple tasks well. 

  • Detail-oriented individual with thorough knowledge of word processing, database, and spreadsheet programs (preferably MS Office).  

  • Must possess the ability to work with internal departments to accomplish objectives and meet established deadlines.  

  • Must be personable, self-starter, possess a good attitude, and enjoy external and internal contact on the phone and in person with supervisors, co-workers, customers, and potential clients. 

 

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. 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. For more information regarding benefits at McKesson, please click here.

Our Base Pay Range for this position

$65,600 - $109,300

McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson’s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:

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


McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.

McKesson job postings are posted on our career site: careers.mckesson.com.

About McKesson

McKesson Corporation provides medicines, pharmaceutical supplies, information and care management products and services across the healthcare industry. The Company operates in two segments. The McKesson Distribution Solutions segment delivers ethical drugs, medical-surgical supplies and equipment and health and beauty care products throughout North America. This segment also provides specialty pharmaceutical solutions for biotech and pharmaceutical manufacturers, sells financial, operational and clinical solutions for pharmacies (retail, hospital, long-term care) and provides consulting, outsourcing and other services. The McKesson Technology Solutions segment delivers enterprise-wide clinical, patient care, financial, supply chain, strategic management and software solutions. In July 2011, the Company acquired Portico Systems from Safeguard Scientifics, Inc. On March 25, 2012, it acquired the independent banner and franchise businesses of Katz Group Canada Inc. McKesson Distribution Solutions delivers pharmaceuticals to retail pharmacies and institutional providers like hospitals and health systems. They operate pharmaceutical distribution centers across the country, serving customers in all 50 states. They also deliver a comprehensive offering of health care products, technology, equipment and related services to the alternate site market, including physician offices, surgery centers, long-term care facilities and home care businesses across the country. McKesson is currently the largest pharmaceutical distributor in North America. McKesson also operates McKesson Canada and has an equity holding in Nadro, a leading distributor in Mexico.

McKesson Careers

Join McKesson, a leading global healthcare company, and be part of a team that is redefining the future of healthcare. With a variety of job opportunities available, McKesson is the perfect place to advance your career, whether you're a seasoned professional or just starting out. Work You’ll Do At McKesson, we are committed to improving care in every setting—one product, one partner, one patient at a time. We’re seeking talented professionals to join our team and contribute to a culture of innovation, diversity, and leadership. Our employees are driven by a deep sense of purpose and a desire for continuous growth and improvement. Empower Your Future in Healthcare With positions ranging from internships to leadership roles, McKesson offers unparalleled employment opportunities to develop your skills and advance your career. Our commitment to diversity training ensures that all team members have the opportunity to thrive. Join a team where your skills will be honed, your professional growth will be supported, and where you can genuinely see the difference you make in the lives of patients around the world. Innovative Work Environment McKesson is at the forefront of healthcare innovation. Our team is constantly exploring new ways to improve patient outcomes and streamline care processes. This commitment to innovation is what sets us apart and what makes McKesson an exciting place to work. Career Development and Benefits McKesson believes in nurturing the potential of its employees through robust career development programs and comprehensive benefits designed to support your life and well-being. From leadership training to health and wellness benefits, we ensure our team members are equipped to meet their professional and personal goals. Explore Job Opportunities Whether you’re looking for an internship to kickstart your career, or a senior position to utilize your extensive experience, McKesson offers a range of opportunities. Explore our open positions and find where you can make a difference at McKesson. Stay Connected Join Our Team Search for open positions that match your skills and interests. We are looking for passionate, curious, and solution-driven team players who are ready to take the next step in their careers. Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Networking and Professional Growth At McKesson, networking and professional growth are part of our everyday environment. We encourage our employees to connect, share, and learn from each other to foster personal and professional development. Job Alert Emails Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await you at McKesson. Join McKesson today and be part of a team that is dedicated to shaping the future of healthcare.
Learn more about McKesson
Size
58,000 employees
Market Cap
$53.7 billion
Industry
Net Income
-$4.1 billion
Founded
1833
5 Year Trend
+5.9%
Revenue
$237.6 billion
NASDAQ

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