Quality Control Specialist - New Oxford, PA

Sartorius Stedim•New Oxford, PA
•Onsite

About The Position

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.

Requirements

  • 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

Nice To Haves

  • Identification with our core values: Sustainability, Openness, Enjoyment

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

Benefits

  • Mentoring
  • leadership programs
  • internal seminar offerings
  • Paid vacation
  • sick time
  • corporate holidays
  • community service day
  • flexible work schedules
  • Comprehensive onboarding, including a virtual online platform
  • Mutual support
  • team spirit
  • international collaboration
  • communities on numerous topics such as “Coaching”, “Agile Working” and a “Businesswomen’s Network”
  • Wide selection of health and well-being support such as a variety of medical plans to choose from
  • dental
  • vision
  • EAP
  • other wellness programs
  • Working in smart buildings with the latest technology and equipment
  • 401 k (with generous company match)
  • HSA
  • FSA (dependent care & healthcare spending)
  • Transportation Commuter Account
  • Basic Life Insurance
  • AD&D
  • EAP
  • Family Planning & Women’s Health
  • Health Advocate
  • Supplemental Life Insurance (employee, spouse & dependents)
  • Legal Services
  • LTD & STD
  • Critical Illness Insurance
  • Student Loan Tuition Refinance Service
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