Quality Assurance Specialist

West Pharmaceutical Services•Williamsport, PA

4d•Onsite

About The Position

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. This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity. The hours for this role are M-F 7:30AM-4:00PM.Job SummaryIn this role the Quality Specialist, Compliance is responsible for maintaining the ongoing compliance of the Quality Management System. Quality Specialist, Compliance is responsible for the administration of the Document Management system on site including coordination of all document change request activities for their nominated area of responsibility. The Quality Specialist, Compliance will provide training and analytical support in the operation of the relevant GMP systems (MasterControl, SAP etc.). The Quality Specialist, Compliance is responsible for supporting the onboarding of new hires including participation in the Induction Program and Annual GMP Training. The role is also responsible for performing data analysis and reporting of Quality System Metrics internally and globally. The Quality Specialist, Compliance will play an active role in ongoing Quality projects as required. Essential Duties and Responsibilities

Requirements

Minimum: 2-years of experience in plastics injection molding and/or blow molding.
Minimum: 3 years of demonstrated experience work in a medical device or pharmaceutical manufacturing environment.
Experience with ISO13485 or 9001
Must have excellent communication and written skills.
Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820/GMP is preferred.
Must be proficient with computers and various software programs such as Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft PowerPoint, Experience with Master Control and SAP would be considered an advantage.
Must be able to work in a fast-paced environment.
Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
Must be able to collaborate across functional lines and work effectively in a team environment.
Strong focus on customer requirements.
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.
Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events
Must maintain the ability to work well with others in a variety of situations
Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and the ability to adjust focus.
Ability to perform basic mathematical tasks like counting, adding, subtracting, and rounding and to record, balance and check for accuracy.
Effectively communicate and interface with various levels internally and with customers

Nice To Haves

Associate’s degree in engineering (industrial, chemical), manufacturing or business administration
A thorough working knowledge of quality systems such as ISO 13485.
21 CFR Part 820 and/or Knowledge of 21 CFR Part 210 / 211 would be considered an advantage.
Auditing experience to CFR 21 Part 820, and / or CFR 21 Part 11 is considered an advantage.
Experience with Master Control and SAP would be considered an advantage.

Responsibilities

Function as Sub Administrator for the site Quality Event Management System to manage and maintain traceable, accountable Quality Records in compliance with Corporate Guidelines
Provide Quality document control oversight on documentation and reports.
Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.
Responsible for management of Systems Training – developing, scheduling, and performing.
Responsible for management of Document Management Training on site – developing, scheduling, and performing.
Responsible for management of GMP Training including Induction and Annual – developing and performing.
Support generation of data for Management Review.
Management of Site Metrics generation (weekly and monthly) including reporting out Globally.
Responsible for ensuring compliance to GMP review requirements to maintain compliance to customer requirements and enterprise procedures.
Work cross functionally with individuals and project teams to ensure successful documentation release.
Acting as compliance representative on Quality Projects within the site.
Participation in Internal Audit Program.
Support in the preparation and hosting of Third-Party Audits including audit training and control room set up.
QMS compliance tracking and trending of issues and patterns to drive improvements.
Interface with other West sites with respect to sharing of best practices.
Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
Compliance to all local site company policies, procedures, and corporate policies.
Other duties as assigned.