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Senior Quality Assurance Specialist - GMP Manufacturing

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Date: Sep 14, 2021

Location: Bethlehem, PA, US, 18017

Company: Lubrizol Corporation

Lubrizol Life Sciences Health's CDMO business 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 LLS Health team, you will be working for a company that is engaged in important, exciting, and socially relevant projects. LLS Health is a fast-paced environment that features a variety of projects, technical challenges, and opportunities for growth. To learn more about us, visit www.particlesciences.com and https://www.lubrizol.com/Life-Sciences.

 

The Senior Quality Assurance Specialist is responsible for ensuring compliant manufacturing activities according to Good Manufacturing Practices (GMP), regulatory guidance, and internal procedures. The Senior QA Specialist will have oversight of daily processes and coordination of tasks within QA and with the Manufacturing group to accomplish this goal; there, excellent organization skills and the ability for open communication is a must.

 

Responsibilities include, but are not limited to:

  • QA oversight during GMP manufacturing processes and coordination of resources to accomplish this task
  • Coordination with Manufacturing for QA availability and support during manufacturing
  • Review of batch records for completeness and appropriate documentation technique
  • Review of other manufacturing documentation such as sampling plans, Master Formula Records, and Master Batch Records for completeness.
  • Oversight of GMP material release and warehouse activities, including documentation and data review.
  • Issuance and reconciliation of all clinical labels
  • Administration of the retain program according to global regulatory requirements

 

Minimum Qualifications:

  • BA or BS degree in a scientific field highly preferred
  • At least 7-10 years of related experience in pharmaceutical industry, or equivalent combination of education and experience with knowledge of current Good Manufacturing Practices (cGMP). Experience with GMP manufacturing activities a plus.
  • Proficient with common PC-based applications, including Microsoft Office
  • 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

 

 

Lubrizol Life Science Health's CDMO business 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

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