Lubrizol Quality Assurance Specialist in Bethlehem, Pennsylvania

Quality Assurance Specialist

REQ ID: 40447

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

As a member of the Particle Sciences, Inc. team you will be engaged in important, exciting, and socially relevant projects. PSI is a great place to work, providing a fast-paced environment with a variety of job assignments, technical challenges, and opportunities. The Quality Assurance Specialist is responsible for fundamental support for cGMP quality systems including supplier control, internal/external auditing, and deviation management.

Essential Duties and Responsibilities

  • Participate in the development, revision, and implementation of QA SOPs to ensure conformance to applicable regulatory standards including, but not limited to, 21 CFR Parts 210/211 and applicable ISO and ICH Guidelines.

  • Support administration of quality processes including Product Quality Complaint Management, Deviation Management, and Investigations ensuring timely completion and efficient resolution of all atypical/non-conforming conditions identified.

  • Support facilitation of audits and inspection administered by health authorities, third-parties and partners as assigned by manager.

  • Responsible for control of cGMP suppliers including oversight of the approval process and all appropriate documentation.

  • Other duties, as assigned by area management.

Knowledge, Skills and Abilities

  • In-depth knowledge of cGMPs and working in a regulated environment following QbD, cGMP and SOPs is required.

  • Demonstrated expertise in regulations & quality systems. Knowledgeable with global pharmaceutical requirements including FDA and EU.

  • Experience writing and reviewing SOPs, protocols, and other regulatory documentation is required.

  • BS/PharmD in Pharmacy, Engineering or related discipline, with a minimum of 5 years of experience in the pharmaceutical or related industry.

Particle Sciences’ headquarters is located in Bethlehem, PA, part of the Lehigh Valley region of Pennsylvania. Lehigh Valley includes the cities of Allentown at http://www.visitpa.com/cities/allentown , Bethlehem at http://www.visitpa.com/cities/bethlehem and Easton at http://www.visitpa.com/cities/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 at http://www.musikfest.org/ festival, to skiing in the Poconos at https://www.poconomountains.com/ , to hiking or biking through the many state parks, you can make it happen right here in the Lehigh Valley at http://www.visitpa.com/regions/lehigh-valley .

Lubrizol is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.

Nearest Major Market: Allentown

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