Quality Systems Specialist Job at Tech Observer, Exton, PA

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  • Tech Observer
  • Exton, PA

Job Description

Contract: 12 Months with a possibility of extension

Work Schedule: Onsite 3 days per week (Monday, Tuesday, Thursday)

Requirement: Prior cGMP and Quality experience required (local candidates only)

Experience – 3 – 5 Years

Job Summary:

  • The Quality Systems Specialist supports regional quality systems activities to ensure compliance with cGMPs, regulatory requirements, and internal standards.
  • This role focuses on SOP management, inspection readiness, quality metrics, and cross-functional collaboration to drive continuous quality improvement.

Key Responsibilities:

  • Perform core regional quality systems activities, including SOP revisions and inspection readiness support, in accordance with established procedures.
  • Develop, improve, and maintain regional quality system SOPs and related documentation.
  • Analyze, track, and report key quality and risk metrics; recommend and support corrective actions.
  • Monitor quality systems to identify gaps, escalate issues, and support timely resolution.
  • Provide project management support for quality systems initiatives and collaborate with cross-functional teams to achieve quality objectives.

Qualifications:

  • Bachelor’s degree in Chemistry, Biochemistry, or a related technical discipline.
  • Minimum 3 years of relevant experience in quality systems (e.g., audits and regulatory inspections, LMS/training operations, document control, electronic quality systems).
  • Strong knowledge of cGMPs and applicable health authority and regional guidelines.
  • Hands-on experience executing quality processes, including SOP/protocol writing, metrics monitoring, and issue resolution.
  • Demonstrated strong performance in prior roles.

Functional Skills:

  • Collaborative team player with the ability to consider and communicate with diverse perspectives.
  • Effective communicator across all organizational levels; able to influence outcomes.
  • Clear, concise, written and verbal communication tailored to the audience.
  • Proactive in escalating issues and seeking support in a timely manner.

Job Tags

Contract work, Local area, 3 days per week,

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