Quality Control Specialist - New Oxford, PA

Sartorius North America; New Oxford (Adams County); On-site; USD 65,000 - 90,000; Full time

Job summary

Sartorius is seeking a Quality Control Specialist to join our on-site team in New Oxford, Pennsylvania. In this role, you'll support the administration, implementation, maintenance, and continuous improvement of our quality management system.

You'll apply established procedures to ensure cGMP compliance with customer requirements and internal quality standards, and collaborate to resolve deviations, CAPA, and training records across functional areas.

Qualifications

• Bachelor degree in Science, Engineering or related field
• 3+ years related experience required
• Knowledge of quality systems and product/process lifecycle management within a manufacturing environment
• Proficient computer skills
• Excellent communications skills both written and oral
• Ability to quickly assess assigned task requirements and communicate effectively to expedite tasks

Responsibilities

• Draft and review Standard Operating Procedures (SOPs)
• Support ongoing process improvement endeavors
• Maintain and ensure applicable regulatory and internal QMS compliance for staff training/personnel files, master schedule, deviation trending/tracking, etc.
• Provide support for internal and sponsored projects including reviewing protocols and reports
• Work collaboratively with staff responding to and resolving deviations and incidents
• Follow through on corrective and preventative actions from deviations and audit observations
• Maintain databases for investigations, audit observations and CAPA

Skills

Quality control

cGMP knowledge

SOP drafting

QMS

Education

BSc/BA in science or engineering

Job description

Sartorius is seeking a Quality Control Specialist to join our on-site team in New Oxford, Pennsylvania. In this role, you'll support the administration, implementation, maintenance, and continuous improvement of our quality management system.

You'll apply established procedures, methods, and quality control techniques to help ensure compliance with current Good Manufacturing Practices (cGMP), customer requirements, and internal quality standards.

What you will accomplish together with us:

• Draft and review Standard Operating Procedures (SOPs)
• Support ongoing process improvement endeavors
• Maintain and ensure applicable regulatory and internal QMS compliance for staff training/personnel files, master schedule, deviation trending/tracking, etc.
• Provide support for internal and sponsored projects including reviewing protocols and reports
• Work collaboratively with staff responding to and resolving deviations and incidents
• Follow through on corrective and preventative actions from deviations and audit observations
• Maintain databases for investigations, audit observations and CAPA

What will convince us:

• Bachelor degree in Science, Engineering or related field
• 3+ years related experience required
• Knowledge of requirements and relevant industry standard practices with a demonstrated ability to interpret these regulations to ensure proper implementation in the quality systems
• Knowledge of quality systems and product/process lifecycle management within a manufacturing environment
• Proficient computer skills required
• Excellent communications skills both written and oral, including ability to navigate potentially challenging situations both internal and external to the business during the coordination of QMS programs
• Ability to quickly assess assigned task requirements, identify potential challenges, and communicate effectively in order to expedite the successful execution of assigned work
• Efficient organizational skills, including the ability to manage multiple processes and priorities effectively
• Identification with our core values: Sustainability, Openness, Enjoyment

What We Offer

As a growing global life science company, with our stock listed on the German DAX and TecDAX , Sartorius offers a wide range of benefits:

Personal and Professional Development: Mentoring, leadership programs, internal seminar offerings

Worklife Balance: Paid vacation, sick time, corporate holidays and community service day; as well as flexible work schedules

Making an Impact Right from the Start: Comprehensive onboarding, including a virtual online platform

Welcoming Culture: Mutual support, team spirit and international collaboration; communities on numerous topics such as "Coaching", "Agile Working" and a "Businesswomen's Network"

Health & Well Being: Wide selection of health and well-being support such as a variety of medical plans to choose from, dental, vision, EAP, and other wellness programs.

Intelligent Working Environment: Working in smart buildings with the latest technology and equipment.

Retirement Savings Plan: 401 k (with generous company match)

Flexible Spending: HSA, FSA (dependent care & healthcare spending), Transportation Commuter Account

Company Paid Benefits: Basic Life Insurance, AD&D, EAP, Family Planning & Women's Health, Health Advocate

Additional/Optional: Supplemental Life Insurance (employee, spouse & dependents), Legal Services, LTD & STD, Critical Illness Insurance, Student Loan Tuition Refinance Service

Sartorius is an equal opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, disability or based on status in any other protected group of class.

Please view equal employment opportunity posters provided by OFCCP here.

E-Verify Participation Info

E-Verify Workers Rights

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking forward to receiving your application.

We look forward to receiving your application.

www.sartorius.com/career

If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening. You can request reasonable accommodation by e-mail at [e-mail]

Sartorius is an equal opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, or disability, or based on status in any other protected group of class.

If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening. You can request reasonable accommodation by e-mail at [e-mail]

About Sartorius

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.

We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking forward to receiving your application.
www.sartorius.com/careers