Project Supervisor jobs

In this role, the Quality Project Manager will support the standardization of QMS process and data management across the organization. This position will lead the development and deployment of quality maturity, QMS improvements and quality cost related measures, evaluations, performance, and initiatives. This position will coordinate activities associated with quality maturity including continuous improvement projects relating to sustaining engineering activities, development of new methods/processes for product evaluation and product development activities through a standardized approach. In addition, this position will deploy highly capable, predictive, effective, and efficient quality cost metrics for West Pharmaceuticals. This position will also be responsible for leading and executing cost improvement initiatives, follow up assessments and action oversight.

• Lead the initiative to standardize quality systems between multiple sites. Identify best practices and ensure roll out to relevant sites.
• Organize and generate detailed quality information reports to show trends and the impact of process improvements.
• Create repeatable methods to assess, measure and communicate the overall quality of a project and deliver key metrics to assess the overall improvement.
• Establish and lead cross functional quality related meetings to review and discuss performance, status and prompting necessary actions as required.
• Manage goals and metrics for Quality teams/initiatives to adequately monitor the overall effectiveness of the teams/initiatives.
• Work with project managers, engineering team, and platform management to develop plans to implement improvement projects.
• Ensures teams work closely with product development, supplier/contractors, design, quality, regulatory teams in order to establish standardized KPIs.
• Work within Quality or across West Divisions to triage Customer Operational difficulties, define root cause(s), and coordinate the implementation of corrective and preventive actions to preclude recurrence related to quality improvements and quality maturity.
• Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
• Support front room and or backroom responsibilities during external audits. Including post audit activities, if required.
• Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
• Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
• Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
• Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members.
• Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
• Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
• Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.
• Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
• May coordinate the activities of one or more exempt and/or non-exempt employees.
• All other duties as required.

• Bachelor's Degree in Science, Engineering or related field

• 8+ years of relevant work experience required

• 5+ years’ experience in pharmaceutical or medical device environment.
• 2+ years’ experience in a Quality role.
• ASQ CQE certification desirable.
• Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
• Knowledge of ISO 9001:2008, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP.
• Ability to manage direct report(s), work independently and in a team environment.
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
• Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
• Experience with SAP is preferred.
• 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.

• • Supervise shift personnel in the manufacture of customer products consistent with high safety and quality standards.
  • Troubleshoot problems arising on the shop floor as it relates to Advanced Manufacturing operations / products, in conjunction with quality standards for throughput and yields with the appropriate engineering support from Engineering functions within the value stream.
  • Maintain close observation of orders to keep informed of manufacturing status and, when needed, initiate the necessary steps to conform to schedule / staffing requirements.
  • Promote and support site initiatives including safety programs, lean initiatives, training programs, and consistently interpret & apply all policies, practices and procedures among plant team members.
  • Recommend and implement measures to motivate team members and to encourage employees to recommend ways to improve process, quality, safety and efficiency.
  • Routinely evaluate team member performance and identify training needs. Coach and counsel team members for performance, attendance and behavior. Participate in the resolution of team members relations issues.
  • Review and approve work time in the appropriate timekeeping system. Maintain and verify accuracy of the hours each team member has worked.
  • Adjust direct labor to support demand and manage available resources to ensure on time production and delivery of customer orders with consistent focus on labor absorption.
  • Ensure Safety regulations, OSHA, SOPs, and cGMP are followed.
  • Perform routine visual inspection of work areas for unusual occurrences, safety hazards, housekeeping, work space organization and generate work orders where appropriate.
  • Network with internal and external customers and other departments as appropriate.
  • Actively participate in site wide Safety Committee Team / projects.
  • Conforms with and abides by all laws, regulations, safety rules, policies, and work procedures, and all instructions.
  • Participate in special project teams as assigned.

• Education: Bachelor's in a technical discipline to include Business, Operations or Engineering preferred

• 5-8 years of experience in a manufacturing environment, including supervisory experience

• Working knowledge of repetitive process, high tech, manufacturing – mechanical automated systems.
• Must possess strong leadership and managerial skills
• General knowledge of OSHA/EPA/safety regulations, manufacturing and process automation
• Working knowledge of business and shop floor systems to effectively manage operations; prefer SPA and MS Office applications.
• Experience working with ISO9000, FDA and cGMP required.
• Ability to speak effectively before groups and employees in the organization.
• Understanding and experience in use of Lean manufacturing principles to be able to support and contribute in 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.

• Health Services\First Aid Certification Upon Hire preferred or
• Health Services\CPR - Cardiac Pulmonary Resuscitation Upon Hire preferred

• Self-motivated and solution-oriented personality.
• Excellent written and verbal skills.
• Good communication, project management, and interpersonal skills.
• Good organizational skills.
• Effective problem-solving skills.
• Must wear safety toe shoes, safety goggles, and hearing protection, as required, in production areas.
• Must follow and comply with Plant’s Dress and Hygiene Code (SOI).
• Must follow and comply with all Company and Plant policies, procedure (SOIs), rules and State and Federal laws

This Full-time onsite role will be supervising, coordinating and administering the site Quality Control systems compliance: Document Control, Nonconformance/ Deviation Reports, OOS Process, Measurement Systems, Change Control, Calibration and CAPA’s. Supervise and support internal projects and ensure cGMP compliance, applicable ISO requirements, company policies and procedures.

• Qualify inspectors to independently perform responsibilities for competency/ proficiency capabilities in inspections, measurements, sampling, Quality audits and defect recognition.
• Qualify and/or support qualification of team members for competency/proficiency in defect and quality incident recognition/escalation.
• Train inspectors in deviation/non-conformance/OOS record initiations, escalations, how to perform containment/bracketing, and initial event triage activities.
• Ensure deviation/ nonconformance reports and OOS’s are completed properly, including root cause investigation (if required), effective corrections and actions closed within an established goal.
• Monitor and enforce compliance to a high level of work standards across the QC functions. Ensure that jobs are carried out efficiently. Paperwork is maintained accurately in accordance with Company policies, Regulatory standards and Training.
• Perform various SAP transactions for maintaining proper product disposition for release criteria and inventory control.
• Analyze data and provide reports/ recommendations to Management for continuous improvement.
• Submit periodic reports on the status of compliance to Quality System requirements.
• Review Customer specifications and ensure requirements are translated into site procedures and documentation as needed.
• Provide for Quality planning by preparing inspection plans and documentation controls.
• Support facilities, equipment and process validations. Approve engineering studies and other protocols as required.
• Ensure proper completion of Change Controls and monitor timely completion when required.
• Monitor completion of MSA’s for critical measurement systems and provide recommendations for gauging improvements.
• Provide expertise and guidance for statistical methods in Production.
• Conforms with and abides by all regulations, policies, work procedures, instructions and all safety rules.
• Performs other duties as assigned based on business needs.
• Exhibits regular, reliable, punctual and predictable attendance.
• Other duties as assigned

• Highschool Diploma required.
• Bachelor's degree in Quality, Engineering, Science or equivalent experience preferred.

• Minimum of 3 years of related experience analyzing information, documentation skills, promoting process improvement and safety management.
• Minimum 1 year of leadership experience or demonstration of leadership skills routinely as part of previous/current role(s)

• Demonstrate a high degree of proficiency in Excel, Word and other Microsoft Office Programs required. Demonstrate oral and written communication skills.
• Familiarity with a variety of Quality concepts, practices, AQL sampling plans for attribute and dimensional inspection. Demonstrate ability to investigate problems and issues in order to determine root cause analysis.
• Familiarity with GMP/GDP Regulations
• 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 make independent quality decisions under pressure, if necessary
• Support and contribute in 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

• Manufacturing environment requires strict adherence to standards. Working environment is a manufacturing facility and must be able to tolerate fumes and particulate generated from the processes.
• Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition.
• Must work constructively in an environment that may have competing resources, while maintaining company confidentiality.
• Must be able to work scheduled work week, plus overtime and/or irregular hours as required to complete assignments.
• May stand or sit for extended periods of time.
• Must transport oneself to and from other areas of the facility and travel to other facilities when necessary.
• Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.

• 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
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• Maintain high attention to detail, accuracy, and overall quality of work.
• Effectively communicate and interface with various levels internally and with customers.
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual

1st Shift Position, with occasional adjustments to accomodate 2nd/3rd shift interactions

In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.

• Establish and successfully executesupplier management planswhich will align to overall business objectives

• Maintain a strong collaborativepartnership

• supplier performanceincluding incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)

• ExecuteSupplier Corrective Action Requests(SCAR) with suppliers, ensuring effective and timely closure

• Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance includingsupplier changerequest.

• Evaluate potential new or future suppliers and support supplierselection processwith the cross-functional team

• Participate in cross-functional teams of design engineering and quality engineering to work with suppliers duringproduct developmentand ensures agreement for manufacturable, cost-effective designs

• Approves components for use in products by drivingProduct Approvalactivities with the suppliers

• Supports Supplier evaluation,auditmanagement and related records

• Supports the evaluation and development ofQuality Agreements and purchasing specificationswith suppliers

• Support the development of anIncoming Inspection strategyon purchased products

• Bachelor's Degree In Engineering or Science required
• Master's Degree In Engineering or Science preferred

• Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry

• Experience working with suppliers and supplier engagement activities

• Knowledge of sterilization process is preferred

• Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations

• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis

• Fluent in English

• Thorough understanding of validation activities and risk management principles and techniques

• Strong problem-solving and critical thinking skills

• Negotiation skills and collaborating with suppliers

• Ability to work under high volume production and fast changing environment

• Willingness to work in a cross-functional team with different time zones

• Able to comply with the company’s safety policy at all times.