QC Coordinator

Description

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

In this role, you will be supporting post-production related Quality activities such as finished batch release, including sterilization and LAL processes release, graphics and work order approval and support additional quality department activities.

Essential Duties And Responsibilities

• Responsible for the commercial (human use) and R&D (Not for Human Use) batch release activities including review and approval of the finished Device History Record documentation and Certificate of Compliance issuing.
• Responsible to review and approve GAMMA/ EtO sterilization documentation, LAL (Endotoxin) test documentation.
• Responsible to review and approve of graphics artwork for Tyvek, Labels and relevant cartons.
• Responsible to approve production/R&D work orders in ERP
• Responsible to review and approve of samples/R&D (not for human use) batch release including review and approval of the finished Device History File documentation and Certificate of Compliance issuing.
• Initiate Nonconforming Product in SAP related to finished batch release and sterilization processes
• Support preparations for periodical management reviews
• Participation in external audits (notified body and customers)
• Write and update quality system procedures
• Support QA dept activities- customer complaints, QA monthly report, KPIs, etc.
  
  

Basic Qualifications

• Education: Practical Eng./ Technical/BA Education-- an advantage
• Minimum 2 years working in quality assurance-- an advantage
• Relevant work history and/or experience may be considered in lieu of above required qualifications
• Experience in the medical device or pharma industry- an advantage
• Excellent written and oral communication skills
• Ability to work independently, multi-task and thrive in fast-paced environment
• Proficient in Microsoft Office Suite including Word, Excel, and Power Point
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy at all times.
  
  

Preferred Knowledge, Languages, Skills And Abilities

• Able to be aware of all relevant standard operating procedures 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 comply with the company’s safety policy at all times.
• Able to always comply with the company’s quality policy.
• Courses on topics related to quality system in the medical device/pharma industry- advantage.
• Adaptable to changes in the work environment, manage QA personnel in competing demands and deal with frequent change, delays or unexpected events.
• Relevant work history and/or experience may be considered in lieu of degree.
  
  

Travel Requirements

• Must be able to travel up to ___0___ % of the time
  
  

Physical & Mental Requirements

• Very Heavy/ Heavy/ Medium/ Light/ Sedentary: ______Sedentary________
• List any mental requirements:
• Adaptable to changes in the work environment, mange competing demands and deal with frequent changes, delays or unexpected events
• Maintain high attention to details, accuracy and overall quality of work
• Maintain the ability to work well with others in variety of situations
• Be able to multi-task. Work under time constrains, problem solve, and prioritize
• Ability to investigate problems and find solutions.
  
  

Delegation/s (Title)

Team Leader, Manufacturing Quality Production

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.