Quality Specialist (cGMP Pharmaceutical) Job at Masis Professional Group, Bethlehem, PA

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  • Masis Professional Group
  • Bethlehem, PA

Job Description

Job Description

Quality Specialist * No C2C or sponsorship available for this job.

$65-75k

Potential Contract-to-Direct for the right person!

Join a fast growing Pharmaceutical Manufacturing site in a long-term contract role as a Quality Specialist. In this position, you’ll play a vital role in driving compliance, elevating operational standards, and supporting the production of critical care products that impact patients worldwide!

Job Summary: Strive to proactively drive the Quality culture at the site and promote cGMP activities. This person will work hands-on with the responsibility of ensuring compliance, improving practices, and qualifying/validating new processes with company strategic goals as a guide. The role may also serve as a liaison between the Operations group and the QA/QC department for day-to-day activities, capital projects, and process improvements.

Essential Duties & Responsibilities

  • Provide documentation and compliance support to meet Global Regulatory Requirements for licensed products.
  • Partner with cross-functional departments to address GMP requirements in validation, investigations, complaints, procedure updates, and change control.
  • Manage multiple priorities while providing leadership, guidance, and feedback to team members.
  • Drive packaging OEE (Overall Equipment Effectiveness) initiatives.
  • Support qualifications, deviations, customer complaints , investigations, and systems compliance.
  • Maintain oversight of the PAS-X system and ensure 24/7 audit readiness.
  • Support regulatory audits with thorough preparation and follow-through.
  • Lead document control activities to ensure accuracy, consistency, and compliance.

Education & Experience

  • Bachelor’s degree or higher in a scientific, quality assurance, or technical field.
  • 1+ years of experience in the pharmaceutical or related regulated industry .
  • Knowledge/understanding of cGMPs, regulatory standards, and industry best practices.
  • Ability to assist in investigations, interpret regulations, and make sound quality decisions.
  • Exceptional verbal and written communication skills with the ability to collaborate across departments and leadership levels.
  • Proficiency in Microsoft Outlook, Excel, Word, and other web-based systems.
  • Strong problem-solving skills with the ability to lead projects and deliver timely results.

Job Tags

Long term contract, Contract work, Worldwide, Visa sponsorship,

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