Specialist, Laboratory Projects

 

• This is a fixed term contract for 9 months.
• This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week.

 

Who We Are:

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary

Laboratory Projects is a global function within the laboratory network at West supporting other functions in analytical questions. As part of this team the job holder will execute analyses based on agreed study protocols or routine work and will primarily focus on particle investigations and identification in support of customer complaints, engineering studies, and root cause investigations. The main responsibilities will involve performing particle and defect analysis and characterization using techniques such as infrared spectroscopy, optical microscopy, and complementary internal or external spectroscopic or imaging methods to identify particulates/defects in pharmaceutical and medical device matrices or various materials based on clients requests/needs.

Essential Duties and Responsibilities

• • Act as project lead for execution of investigations relating to particle analysis
  • Support the West plants on particle analysis using the µATR method
  • Liase with other West laboratories on best practice for particle analysis using µATR method
  • Author protocols and reports for lab projects
  • Prepare trends and technical reports based on data with guidance from lab management
  • Participate in lab projects such as Method Transfers, Verifications, Validations and Equipment Qualifications
  • Perform physical, chemical and chromatographic testing to support the plant functions globally as part of laboratory studies
  • Prepare and update Control forms, SOIs, and general lab documentation
  • Maintain cGMP and ISO compliance
  • Support audit preparations and maintain an audit ready lab environment.
  • Be willing and able to work as a team member to ensure continuous improvement relative to laboratory functions.
  • Develop ability and competence with analytical techniques.
  • Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
  • Compliance to all local site Environmental, Health and Safety regulations and contribution to Improvement of Safety in the Laboratory.
  • Compliance to all local site company policies, procedures and corporate policies.
  • Any other duties assigned.

Education

• Degree in Chemistry or science related discipline

Preferred Knowledge, Skills and Abilities

• • 3-5 Years experience working in a GMP-regulated environment, with practical expertise in laboratory testing and execution of small-scale projects
  • Effective communication & interpersonal skills.
  • Working in global, cross-functional teams.
  • Ability to work in a rapidly moving and partly undefined (“grey area”) regulatory environment.
  • Patient and tenacious, proactive working style.
  • Background in analytical laboratory testing and in Compendia regulations is an advantage.
  • Background in Industry Standards applicable to the pharmaceutical (packaging) industry, such as ISO, ASTM, Compendia, ISPE, ICH is an advantage.
  • Strong Quality and customer-focused mind-set.
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
  • Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
  • Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the posit