Quality Assurance Technician

West Pharmaceutical Services • Williamsport, PA

5d • Onsite

About The Position

In this role, you will perform a variety of tasks and conduct 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.

Requirements

• High School Diploma or GED Required
• Experience: 3 years of job-related experience; in QA/QC and the use of measuring equipment.
• 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.
• 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.
• 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.
• Ability to learn, understand, and remember normal tasks.
• Ability to hear, speak, and understand conversation in English in a normal tone of voice.
• 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

• Associates Degree in Metrology or Quality related fields
• 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.

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

Benefits

• benefit programs
• empower the physical, mental, emotional and financial health of our team members and their families
• giving back to help those in need in the communities where we live and work
• creating a healthier environment and planet through our sustainability efforts

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED