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Title:  Quality Engineer, Mixing Control

Requisition ID:  52375
Date:  Sep 6, 2022
Location: 

Williamsport, Pennsylvania, US

Department:  Quality
Description: 

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

The person in this role will be responsible for the implementation and qualification of equipment used in the QC Mixing Control, as well as supporting of the test method transfers. Upon implementation the person would be responsible for scheduling and supervision of the Quality Technicians/Inspectors. The candidate will be a hands-on contributor to West’s success and culture of continuous improvement. The candidate will be directly involved in testing, measuring, and analyzing data, implementing corrective actions, and improving products, services, and processes. A significant amount of the workday will be spent in the production and QC areas. Another key component of this position is supporting cross-functional corrective actions and continuous improvement projects in QA/QC, Process Engineering, and Production, at the site, intra-site, and corporate levels

 

Essential Duties and Responsibilities:

  • Responsible for maintaining validated status of equipment’s used in the Mixing Control lab.
  • Ensure the calibration and maintenance status of test equipment.
  • Support in the validation and qualification of devices including documentation and implementation.
  • Supervision of Quality Technicians/Inspectors, responsible for testing of compounding batches.
  • Responsible for organization / work schedule planning for the Quality Technicians/Inspectors on the respective shifts.
  • Training and development / promotion of the Quality Technicians/Inspectors by conducting training courses, qualifications, or similar.
  • Supporting the Quality Technicians/Inspectors in completing the test tasks through active participation / testing.
  • Responsible for compliance with GMP and ISO guidelines and the implementation of internal SOI’s and guidelines.
  • Ensure all compounded batches are tested properly and on time in accordance with the existing SOI.
  • Responsible for control of documentation.
  • Responsible for investigation (Deviation / OOS) and control of rejected materials using SAP.
  • Responsible for disposition of materials in SAP.
  • Assist in meeting department and site KPI’s.
  • Active support in further development of test methods and processes as applicable.
  • Participation in risk analysis, and continuous improvement plans.
    • Join Tier meetings and keep close collaboration with Compounding dept.
    • Contribute to the Quality culture, support creation and execution of GMP and quality trainings of Compounding dept personnel.
  • Support / participation of customer audits.
  • 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:

  • Bachelor’s degree in Engineering, Biology, or Business.
  • Minimum 3yrs experience in a Quality or Engineering role at a manufacturing company.
  • Ability to read and interpret technical drawings and documents.
  • Demonstrate personal initiative and accountability by proposing creative and innovative solutions while actively driving improvement activities forward.
  • Able to comply with the company’s safety policy at all times.
  • Able to comply with the company’s quality policy at all times.
  • Able to be aware of all relevant SOPs and Company policies related to duties in this Job Description.

 

 

Preferred Knowledge, Skills and Abilities:

  • Minimum of 3yrs experience in a Quality or Engineering role at a pharmaceutical, medical device, or other regulated manufacturer
  • Six Sigma Green Belt
  • Knowledge of Lean, Six Sigma, DMAIC, PDCA, Root Cause Analysis, Corrective Action, Problem Solving
  • Experience with statistical processing software (Minitab highly preferred)
  • Experience with Material or Enterprise Resource Planning (MRP or ERP) system (SAP highly preferred)
  • Knowledge of ISO 9001, ISO 13485 or 15378, 21 CFR 820, 21 CFR 210 & 211, cGMP
  • Experience auditing processes and products

 

 

Travel Requirements:

  • Must be able to travel up to 10% of the time

 

Physical and Mental Requirements:

  • Ability to learn, understand, and remember normal tasks.
  • Ability to hear, speak, and understand conversation in English in a normal tone of voice.
  • 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.
  • Use written and verbal communication skills to all levels of the organization.
  • Read and interpret data, information, and documents.
  • Analyze and solve problems.
  • Observe and interpret situations.
  • Learn and apply new information or new skills.
  • Work under deadlines with constant interruptions.

 

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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