Supervisor, Quality Systems

West Pharmaceutical Services•Jersey Shore, PA

46d

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. Job SummaryManage, coordinate and administer the site quality systems compliance: Document Control, CAPAs, Change Control, OOS, Deviation Reports. Manage and support internal projects and ensure compliance with cGMP, applicable ISO requirements and company policies and procedures.Essential Duties and Responsibilities Manage and support Document Control activities Manage the CAPA process including the review and approval to open new CAPA as well as approving CAPA plans, timelines and verification of effectiveness plans to assure timely completion within the established goals. Ensure deviation and nonconformance reports and OOS are completed properly, including root cause investigation (if required), effective correction(s) and corrective action(s) and closed within the established goal. Support Technology Transfer process as required. Support validation of facilities and equipment and process. Approve engineering studies and other protocols as required Analyze data and provide reports and recommendations to management for continuous improvements Ensure proper completion of Change Controls and monitor timely completion. Approve Change Controls for QA as needed. Manage and oversee site quality specialists. Review/approve customer specifications and ensure requirements are translated into site procedures and documentation. Provide for quality planning by preparing control plans and inspection documentation Define strategic plan to meet company and site goals Submit periodic reports on the status of compliance to quality system requirements Monitor and provide guidance to pest control service provider. Communicate pest control issues and ensure resolution. Provide expertise and guidance for deployment of statistical methods in production. Performs other duties as assigned based on business needs. 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

Requirements

Bachelor’s degree Quality, Engineering preferred
at least 3 years of experience
One (1) year managing others directly
Demonstrated high degree of proficiency in MS Word, Excel and other Microsoft Office Programs required.
Demonstrated excellent communication skills both oral and written.
Demonstrated ability to investigate problems and issues in order to determine the root cause of failures
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.
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.
Must also be able to maintain confidentiality and resolve conflicts.
Ability to make independent and sound judgments.
Use written and oral communication skills
Read and interpret data, information and documents
Analyze and solve problems
Use simple arithmetic reasoning
Observe and interpret situations
Learn and apply new information or new skills
Work under deadlines with constant interruptions

Nice To Haves

Training in Six Sigma methodology
Working familiarity with Project Management tools and Quality Risk Management
Working knowledge of Pharmaceutical Industry requirements
Support and contribute in Lean Sigma programs and activities towards delivery of the set target

Responsibilities

Manage and support Document Control activities
Manage the CAPA process including the review and approval to open new CAPA as well as approving CAPA plans, timelines and verification of effectiveness plans to assure timely completion within the established goals.
Ensure deviation and nonconformance reports and OOS are completed properly, including root cause investigation (if required), effective correction(s) and corrective action(s) and closed within the established goal.
Support Technology Transfer process as required.
Support validation of facilities and equipment and process.
Approve engineering studies and other protocols as required
Analyze data and provide reports and recommendations to management for continuous improvements
Ensure proper completion of Change Controls and monitor timely completion.
Approve Change Controls for QA as needed.
Manage and oversee site quality specialists.
Review/approve customer specifications and ensure requirements are translated into site procedures and documentation.
Provide for quality planning by preparing control plans and inspection documentation
Define strategic plan to meet company and site goals
Submit periodic reports on the status of compliance to quality system requirements
Monitor and provide guidance to pest control service provider.
Communicate pest control issues and ensure resolution.
Provide expertise and guidance for deployment of statistical methods in production.
Performs other duties as assigned based on business needs.
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