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Quality Assurance Specialist

2 months ago

Elkridge, Maryland, United States Piper Companies Full time

Piper Companies is seeking a highly skilled Quality Assurance Specialist to join their team in a 100% on-site role.

Key Responsibilities:

  • Conduct thorough audits of internal and external vendors and suppliers to ensure compliance with established procedures and regulations.
  • Develop and implement new Standard Operating Procedures (SOPs) and revise existing ones as needed to maintain quality standards.
  • Manage quality records, including Deviations, Change Controls, CAPAs, and Out of Specification (OOS) records, to ensure timely closure and compliance.
  • Perform technical reviews of manufacturing batch records to ensure adherence to established procedures, regulations, and quality standards.
  • Conduct quality assurance activities on the production floor, including room release, observing critical processes, and reviewing batch documentation in real-time.

Requirements:

  • Minimum 2 years of relevant experience in the pharmaceutical, biotechnology, or biopharmaceutical industry.
  • Proven experience in batch record review, out-of-specification results, and CAPA investigations.
  • Familiarity with electronic documentation Quality Management Systems is a plus.
  • Bachelor's degree in life sciences, preferably biology or chemistry.

Compensation Package:

  • Salary Range: $70,000-$80,000 based on experience.
  • Comprehensive Benefits: medical, dental, vision, prescription coverage, 401(k) plan.
  • Perks: Employee Wellness resources, Paid Time Off (PTO).

Key Skills:

  • Quality assurance and control.
  • Regulatory compliance.
  • Batch record review.
  • Out-of-specification results.
  • CAPA investigations.
  • Electronic documentation Quality Management Systems.