Document Control Coordinator - Entry Level

This position is Monday - Friday 8:00 AM - 5:00 PM 

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 support all quality system and functions for a medical device manufacturing facility. Assists in establishing systems to support the facility to drive continuous improvements and minimize the costs of non-conformance. Plans, schedules, executes and communicates all items regarding quality issues, complaints, validations and other projects to the QA Manager and/or other interested parties. Performs all duties associated with compliance-related items for ISO standards and cGMPs.

Essential Duties and Responsibilities:

• Support site Quality Engineers/Quality Specialists in meeting customer expectations in complaint investigation responses. Aid in assuring expected turn-around time metric is attained. 
• Support site Quality Engineers, Manufacturing/Project Engineers, and other site staff in investigating CAPAs and executing implementation of corrective action plans. Aid in assuring expected turn-around time metrics are maintained.
• Assist in developing site Quality Engineer staff in usage of tools and processes for customer complaint investigations/continuous improvement.
• Analyze data, process capabilities, customer concerns and expectations and any other leading or lagging indicators which may be used to improve product and process knowledge. 
• Identify manufacturing and development constraints. Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence.
• Assists facility with quality improvement programs by utilizing Six Sigma tools and Lean techniques, including the education of facility personnel on these tools and techniques
• Assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or processes, including development and implementation of any new or required inspection methods and in-process SPC programs.
• Participates in ISO and corporate quality system audits.
• Utilizes knowledge of International Standards and Federal Regulations (i.e. ISO 13485/21 CFR 820) to maintain the quality management system.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

• Exhibits regular, reliable, punctual and predictable attendance.
• Other duties as assigned.

 

Basic Qualifications: 

• Strong analytical thinking and complex problem-solving skills
• High School Diploma or GED.
• Experience working within FDA CFRs or other regulated environments.
• Experience completing CAPAs and/or complex investigations.
• Minimum of 1 year of experience in the same or similar role.

 

Preferred Knowledge, Skills and Abilities:

• Able to interface with customers and meeting customer expectations.
• Experience operating within the Medical Device regulations.
• Ability to work with interdisciplinary teams.

• Experience with Project Management tools and able to provide support and contribute in Lean Sigma programs and activities towards delivery of the set target.
• Willingness to learn manufacturing procedures and aid with improvements via Quality Management.
• 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.
• Able to comply with the company’s quality policy at all times.

 

Travel Requirements:

• None.

 

Physical and Mental Requirements:

• Need to have extreme attention to detail.