Quality Assurance Specialist

1 day ago


Elkridge, Maryland, United States Piper Companies Full time
Job Description:

Piper Companies is seeking a highly skilled Quality Assurance Specialist to join our team in a 100% on-site role. As a Quality Assurance Specialist, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing processes.

Key Responsibilities:
  • Internal and External Vendor Audits: Conduct thorough audits of internal and external vendors to ensure compliance with established procedures, regulations, and quality standards.
  • Standard Operating Procedure (SOP) Development and Revision: Develop and revise SOPs as needed to ensure compliance with regulatory requirements and industry standards.
  • Quality Record Management: Initiate, track, and close quality records such as Deviations, Change Controls, CAPAs, and Out of Specification (OOS) records.
  • Batch Record Review: Conduct thorough technical reviews of manufacturing batch records to ensure compliance with established procedures, regulations, and quality standards.
  • Quality Assurance on the Floor: Perform QA activities on the floor, including room release, observing critical processes, and reviewing batch documentation in real-time.
Qualifications:
  • Experience: 2+ years of relevant experience in the pharmaceutical, biotechnology, or biopharmaceutical industry.
  • Batch Record Review Experience: Experience with batch record review, out-of-specification results, and CAPA investigations.
  • Quality Management Systems: Knowledge of electronic documentation quality management systems is a plus.
  • Education: Bachelor's degree in life sciences, preferably biology or chemistry.
Compensation and Benefits:
  • Salary Range: $70,000-$80,000 based on experience.
  • Comprehensive Benefits Package: Medical, dental, vision, and prescription coverage, 401(k), and employee wellness resources.
  • Perks: PTO and a comprehensive benefits package.


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