Quality Assurance Technician

West Pharmaceutical Services•Loyalsock Township, PA

2d•Onsite

About The Position

At West, we are a dedicated team focused on improving patient lives, a purpose that has driven the company for over a century. Our history began with Herman O. West's solution for mass penicillin supply during World War 2. We deliver thousands of life-saving and life-enhancing injectable medicines daily. We offer an inclusive community with opportunities for lifelong learning, growth, and development, supported by benefit programs that empower the physical, mental, emotional, and financial health of our team members and their families. We are committed to giving back to communities and creating a healthier environment through sustainability efforts. In this role, the Quality Assurance Technician will perform various tasks and conduct test procedures related to the quality process, ensuring that high standards of quality are achieved and maintained. This position reports directly to the Quality Supervisor.

Requirements

High School Diploma or GED Required
3 years of job-related experience in QA/QC and the use of measuring equipment
Ability to learn, understand, and remember normal tasks
Ability to hear, speak, and understand conversation in English
Must maintain the ability to work well with others in a variety of situations
Must be able to multi-task, work under time constraints, problem solve, and prioritize
Read and interpret data, information and documents
Work under deadlines with constant interruptions

Nice To Haves

Good communication/interpersonal skills
Detail oriented, organized, flexible and able to handle multiple tasks and time critical projects/deadlines
Understand the principles of Batch Control and FIFO
Ability to hold a high degree of confidentiality
Knowledge of GMP
Computer literacy
Third level qualification in Quality/Mechanical/Plastic Engineering and/or relevant industrial experience in a high-volume injection-molding environment
Basic knowledge of statistical sampling of product
Understanding of injection molding processes
Working knowledge of ISO 9001/ ISO 13485 and FDA Code of Regulations CFR part 820 preferred
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 comply with the company’s quality policy at all times

Responsibilities

Review and approval of metrology reports, where appropriate, for batch release and validation purposes
New product validation, analysis and reporting
Quality support to Engineering and Production Departments
Establish and maintain documentation in line with West Williamsport and West Pharmaceutical Services Quality Systems
Liaise with customers and suppliers on new and existing projects
Receiving and inspection of incoming goods and materials
Ensure that all parts/ materials, which require incoming inspection, conform to all requirements and applicable drawings and specifications
Maintain good communications both internally and externally
Ensures that all metrology equipment is correctly calibrated
Assists shift personnel with quality issues and/or measurement techniques
Assists in problem resolution with customers
Perform periodic audits as requested and completes necessary documentation
Archives quality records, samples and log procedures
Makes periodic clean-out of records and samples exceeding minimum retention requirements as per West procedures
Batch paperwork review and final decision to release product for shipment
Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct
Compliance with all Environmental, Health and Safety requirements, training and regulations
Compliance with all site policies, procedures and corporate policies
Perform additional duties at the request of the direct supervisor
Other duties as assigned
Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards
Maintain a clean, orderly, and safe workstation and environment at all times
Conform with and abide by all regulations, policies, work procedures, instruction, and safety rules
Exhibit regular, reliable, and punctual attendance
Perform other duties as assigned based on business needs
Keep current with new GMP compliance guidance and internal QA procedures
Support new GMP compliance guidance and Data Integrity initiatives