Quality Control Specialist - New Oxford, PA

Posted Yesterday
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New Oxford, PA, USA
In-Office
Mid level
Biotech
The Role
Supports the quality management system in a cGMP manufacturing environment by drafting and reviewing SOPs, maintaining compliance records and databases, tracking deviations and audit observations, supporting investigations and CAPA, reviewing project protocols and reports, and coordinating process improvements and corrective actions.
Summary Generated by Built In
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 [email protected]

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 [email protected]

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

Skills Required

  • Bachelor's degree in Science, Engineering, or a related field
  • 3+ years of related experience
  • Knowledge of regulatory requirements and relevant industry standard practices
  • Ability to interpret regulations and implement them within quality systems
  • Knowledge of quality systems and product/process lifecycle management in a manufacturing environment
  • Proficient computer skills
  • Excellent written and oral communication skills
  • Ability to coordinate quality management system programs and navigate challenging situations
  • Ability to assess task requirements, identify challenges, and communicate effectively
  • Strong organizational skills and ability to manage multiple processes and priorities

Sartorius Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sartorius and has not been reviewed or approved by Sartorius.

  • Healthcare Strength Health coverage includes multiple medical plan options with dental, vision, HSA/FSA, EAP, and wellness resources across many locations. Quality of core medical, dental, and vision is characterized as solid.
  • Retirement Support Retirement offerings include a 401(k) with a company match highlighted in U.S. materials and employer‑verified listings. The match is characterized as generous at some sites.
  • Flexible Benefits Flexible hours and hybrid/home‑office options are available where roles and regions allow, with role‑dependent perks in some locations. Broader extras such as commuter benefits, discounts, and tuition assistance add optionality where eligible.

Sartorius Insights

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The Company
HQ: Göttingen
9,059 Employees
Year Founded: 1870

What We Do

Sartorius is a leading international partner of life sciences research and biopharmaceutical manufacturing. We help our customers #SimplifyProgress from drug discovery to manufacturing so that more people can have access to better medicine. With this, we are #PartOfTheSolution in the fight against diseases worldwide. With innovative laboratory instruments and consumables, the our Lab Products & Services division focuses on laboratories performing research and quality control at pharmaceutical and biopharmaceutical companies as well as academic research institutes. The Bioprocess Solutions division, with its broad product portfolio focusing on single-use solutions, helps customers manufacture biotech medications, vaccines, and cell and gene therapies safely, rapidly, and economically. Based in Göttingen, Germany, Sartorius also has a strong global reach with around 60 production and sales sites worldwide. We regularly expand our portfolio through the acquisition of complementary technologies. In 2023, Sartorius generated sales revenue of around 3.4 billion euros. Currently, around 14,600 employees from around 110 nations are working for customers around the globe. Join our team, partner or collaborate with us.

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