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Quality Specialist

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Date: Feb 21, 2021

Location: Bethlehem, PA, US, 18017

Company: Lubrizol Corporation

 

Particle Sciences, A Lubrizol Company is the leading CDMO for complex formulation development for the pharmaceutical industry, with over 20 years of successful experience and a solid base of clients ranging from the world’s largest pharmaceutical and biotech companies to small VC backed start-ups. As a member of the Particle Sciences, Inc. team, you will be working for a company that is engaged in important, exciting, and socially relevant projects. Particle Sciences is a fast-paced environment that features a variety of projects, technical challenges, and opportunities for growth. To learn more about Particle Sciences, A Lubrizol Company, visit www.particlesciences.com and https://www.lubrizol.com/Life-Sciences.

Particle Sciences, Inc. in Bethlehem, PA has an immediate opening for a Quality Assurance Specialist.

 

Quality Assurance Specialist – Deviations/Investigations/CAPA

The Quality Assurance Specialist is responsible for maintaining the deviation, CAPA, Out of Specification (OOS), Out of Expectation (OOE), and Microbial Excursion programs to support Good Manufacturing Practices (GMP). The QA Specialist will have oversight of the aforementioned areas and maintain the daily processes and ensures documents are being completed within the appropriate timeframe.

 

Key Responsibilities:

  • Responsible for maintaining the deviation and CAPA program.
  • Lead and assist others in executing investigations, root cause analyses, and CAPAs.
  • Trains and guides employees on writing deviations, OOS, OOT, and CAPAs.
  • Reviews and approves deviations and CAPAs.
  • Ensure deviations and CAPAs are completed within the appropriate timeframe.
  • Maintain trending logs for deviations, CAPAs, OOS, OOE, and Microbial Excursions.
  • Responsible for maintaining the OOS and OOE process.
  • Responsible for maintaining the Microbial Investigation tracking and completion.
  • Performs other QA duties as assigned.

 

Minimum Qualifications:

  • BA/BS degree preferably in a scientific field
  • 5-10 years of related experience in pharmaceutical industry, or equivalent combination of education and experience with knowledge of current Good Manufacturing Practices (cGMP)
  • Previous experience with deviations is required
  • Proficient with common PC based applications and specifically in the use of MS Office, knowledge of the NuGenesis system is a plus
  • Excellent verbal, written communication and organizational skills. Demonstrated independent analytical and problem-solving abilities.
  • Position will involve standing for extended periods of time and minimal lifting.

 

Particle Sciences’ headquarters is located in Bethlehem, PA, part of the Lehigh Valley region of Pennsylvania. Lehigh Valley includes the cities of Allentown, Bethlehem and Easton. The region is slightly over an hour to both Philadelphia and New York City, which places you right in the action. Buzzing with business, culture, knowledge and entertainment, the Lehigh Valley is a vibrant place for people of all ages and walks of life to live, learn, work and play.  This region offers a little bit of everything for everyone - ethnically-diverse communities, affordable housing, award-winning schools and universities, world-class healthcare, ski resorts, museums, casinos, shopping, restaurants, sports and nightlife. From the yearly Musikfest festival, to skiing in the Poconos, to hiking or biking through the many state parks, you can make it happen right here in the Lehigh Valley.

 

Lubrizol is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to sex, race, color, national origin, citizenship, age, religion, marital status, military service, sexual orientation, genetic information, gender identity, or any other characteristic or trait protected by federal, state, or local law.

 

Do You Need Assistance?

Please let us know if you need an accommodation to proceed with your application for a posted job, or with any other aspect of the interview or assessment process.  You can either call 440-943-4200 and ask for Talent Acquisition or send an email to talentacquisition@lubrizol.com. Please note that this phone line and email address are not to be used for checking on the status of an already submitted application and not to be used by third party recruiters.


Nearest Major Market: Allentown

Job Segment: Biotech, CAPA, Pharmaceutical, Quality Assurance, Quality, Science, Management, Technology