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Quality Control Manager

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Date: May 6, 2022

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.

 

Essential Duties and Responsibilities

All duties and responsibilities of job description Commercial Quality Control Manager:

  • Managing the commercial laboratory capabilities.
  • Maintaining and upgrading the GMP laboratory areas, having them ready when needed for client and internal projects.
  • Oversee the environmental monitoring program including generation of documentation such as risk assessments and trending reports.
  • Coordinating scheduling of analytical testing, environmental monitoring, cleaning and qualifications.
  • Ensuring equipment needed for commercial laboratory testing has been properly qualified for use in the Quality Control laboratory.
  • Ensuring consumables and other materials needed in the Quality Control laboratory are available and appropriate for GMP testing.
  • Provide technical guidance to operations and other support areas regarding EM and sterility assurance matters.
  • Writing, reviewing and editing SOPs associated with the Quality Control laboratory.
  • Writing, reviewing and editing GMP documentation such as Test Methods, Specifications, Method Transfer, Method Validation, etc.
  • Oversees all commercial Quality Control laboratory testing and processes.
  • Participates in Project Teams approaching and during the commercial Quality Control testing stage.
  • Participates as an integral part of planning and execution when commercial Quality Control testing is called for.

 

Knowledge, Skills and Abilities

  • BA/BS/MS degree preferably in a scientific field.
  • 5+ years of related experience in pharmaceutical industry, or equivalent combination of education and experience with knowledge of current Good Manufacturing Practices (cGMP)
  • Proficient with common PC based applications and specifically in the use of MS Office
  • Has high-level user skills with MS Word, Excel, PowerPoint, Access, project and Outlook
  • Knowledge of laboratory safety precautions and protocols for safe handling and the disposal of hazardous agents/reagents, chemicals and materials
  • Knowledge of the design and operation of laboratory equipment under GMPs
  • Mechanical/technical ability to learn about the design and operation of new laboratory equipment
  • Organization, communication, planning and analytical skills
  • Ability to understand and effectively communicate technical and business information, both oral and written to others, including co-workers, supervisors, subordinates, clients, and vendors
  • Intermediate mathematical skills, including: algebraic functions, statistics (mean, median, standard deviation, variance, probability), basic geometry (area, volume calculations), and scientific calculators
  • Ability to define problems, collect data, establish facts, and draw valid conclusions
  • Ability to work varied and extended hours/days, as business dictates

 

Qualification Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions.

  • Physical Demands
  • Regularly lift/carry/move up to 10 pounds, and occasionally lift/carry/move up to 50 pounds
  • May require standing for extended periods of time
  • This position requires the use of respirators.
  • Employees must pass the medical evaluation and fit test to be eligible for respirator use.
  • Proper fit testing requires the employees to be clean shaven.

 

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

Job Segment: Biotech, QC, Manager, Pharmaceutical, Quality, Science, Management