Quality Assurance Technician

In this role, you will perform a variety of tasks and conducts test procedures in regard to the quality process, ensuring that the pre-determined high standards of quality are achieved and maintained. Reporting directly to the Quality Supervisor., * 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.

Additional Responsibilities

• 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, This position will train on day shift for several weeks and then transition to a 2-2-3-2 Night Shift 5:45 PM - 6:00 AM.

• High School Diploma or GED Required

• Associate's degree in Metrology or Quality Assurance.

Work Experience

• Experience: 3 years of job-related experience; in Quality Assurance/Quality Control and the use of measuring equipment. Experince in experience in a plastics manufacturing environment preferred.

Preferred Knowledge, Skills and Abilities

• Must possess good communication/interpersonal skills; must be detail oriented, organized, flexible and be able to handle multiple tasks and time critical projects/deadlines.
• Must understand the principles of Batch Control and FIFO.
• Must be able to hold a high degree of confidentiality.
• Must have knowledge of GMP.
• Computer literacy required.
• Ideally have a third level qualification in Quality/Mechanical/Plastic Engineering and/or have 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.

Travel Requirements

None: No travel required

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Additional Requirements

• 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

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.