Quality Control Specialist

  • ExtremityCare
  • Conshohocken, PA
  • Quality Control
  • Full Time
  • Director of Quality Control
  • Exempt
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The Quality Control Specialist is responsible for ensuring that all products and quality control processes meet established quality requirements.


Duties & Responsibilities:

  • Inspect HCT/P products in accordance with standard operating procedures and regulatory requirements.
  • Sort and segregate acceptable and unacceptable HCT/P products.
  • Prepare shipping documents and packages in accordance with standard operating procedures.
  • Communicate and escalate inspection or quality control issues to Management/Quality Control as necessary.
  • Initiate and review quality control records to include environmental monitoring, and HCT/P inspection.
  • Assist in routing, editing, and finalizing controlled documents, ensuring consistency and compliance to formatting and template requirements.
  • Initiate, review, and investigate quality events.
  • Support internal and external audits.
  • File and maintain records in accordance with standard operating procedures.
  • Maintain a proficient working knowledge of AATB Standards, cGMP/cGTP, and the organizations Policies and Procedures.
  • Starting your job duties on time, staying on the job throughout the assigned shift to complete duties properly, and attending all scheduled meetings and appointments
  • Perform other related duties as assigned.


Skills & Abilities:

  • Excellent attention to detail and organization skills
  • Self-motivated
  • Ability to work in a fast-paced environment.
  • Effective verbal and written communication skills.
  • Ability to secure and maintain a favorable background investigation and clearance


Education & Experience:

  • Entry Level position
  • Bachelor’s degree in a biological science or related field
  • 0-1 year of quality experience in an FDA regulated environment for HCT/Ps and/or medical devices preferred

Quality Control Manager - Quality Assurance

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