Spec, Quality Assurance

 

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, assist manufacturing personnel when making decisions as to quality of our product.  Support and drive programs set up by Q. A. to improve the efficiency of plant operations such as through the application of SPC, auditing, validations, and training.  Act as a liaison between Quality Assurance and the Processing, Manufacturing Maintenance, shipping, and warehousing functions. Be a Quality Resource in the improvement of all aspects of plant operations and in the plant’s relations with its customers and suppliers.

 

Essential Duties and Responsibilities:

• Perform the necessary functions in support of the Williamsport quality system
  • Assist in maintaining and improving all facility required quality systems including ISO 13485 (current version), and related HACCP requirements
  • Designated HACCP Manager.
  • Serve as quality resource to assist manufacturing, engineering, sales and the customer in evaluating and resolving quality related problems and issues.
  • Review and assist on the updating of customer specifications. Respond to customer/sales regarding the approval or recommended changes to these specifications and maintain a file of the responses and the specifications.
  • Participate in customer, regulatory, and internal audits of the plant; participate in supplier audits as directed by the QA Manager.
  • Assist in the coordination of the QA internal audit program and hold a lead auditor certification.
  • Assure that all customer complaints are investigated, and a response is issued in a timely manner. Maintain the customer complaint file and generate reports on a periodic basis.   
  • Maintain various quality tracking databases.
  • Designated back up to the Document Control Coordinator.
• Perform administrative duties for the Master Control system including, but not limited to:
  • Document control, customer specifications, Issue reviews, CAPA’s, etc.
  • Assist in the review of quality system procedures to assure the manufactured product meets customer specifications. 
  • Perform sub-administration duties regarding security and limited technical support (system navigation and answering basic user questions).
  • Support essential programs which benefit manufacturing, engineering, validations and process improvement projects in cooperation with other departments.

• Support the application of SPC, provide SPC training as required and aid in analyzing and interpreting SPC data.
  • Participate in Lean Initiatives, as assigned.
  • Maintain customer specs, COA, COC, inspection plans, and material master in the SAP system. 
  • Facilitate the Pest Control program.
• Actively participate and comply with all West HSE programs and regulations.
• Maintain a neat and orderly work environment in accordance with West 5S program.
• Other duties as assigned.

 

Basic Qualifications:

• Preferred: Four-year College graduate in Manufacturing Engineering Technology with a minimum of 2-years of experience in plastics injection molding and/or blow molding. 
• Minimum: Two-year college degree in a technical discipline or a minimum of 5-7 years of experience in a manufacturing environment.

 

Preferred Knowledge, Skills, and Abilities:

• Must be familiar with computers and various software programs such as Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft PowerPoint, Master Control, SAP, and GageTrak.
• Understanding of Statistical Process Control, blueprint reading and use of measuring/testing equipment.
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by