QC Compliance Specialist - Microbiology

Paragon Bioservices   •  

Baltimore, MD

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 39 days ago

Paragon Bioservices is a contract development and manufacturing organization (CDMO) whose focus is the development and manufacturing of cutting-edge biopharmaceuticals. We provide industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. Paragon's scientists, engineers, quality experts, manufacturing operators and programmanagers are experts working with biologics from research and process development to GMP manufacturing for clinical trials and commercial launch.

This role is responsible for supporting compliance in the Quality Control Microbiology Laboratory, including investigation/deviation management, CAPA tracking, change control and critical facilities/utility qualifications. This position will facilitate the compiling, trending and reporting key quality microbiology metrics for management, and other quality control microbiology functions, as needed. Continuously monitor systems, programs such Environmental Monitoring and compendial testing procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.

Key Responsibilities include but are not limited to:

  • Supports and ensures timely initiation, write up and closure of QC CAPAs, Investigations, Deviations and Change Controls.
  • Responsible for tracking and trending aspects of Quality Control Microbiology Systems and provide reports to management identifying risks and trends on a routine basis.
  • Works with Quality Systems group to perform QC CAPA effectiveness evaluation based on quantitative and qualitative measurements.
  • Maintains tracking mechanisms to support various QC related microbiology metrics.
  • Continuously monitor and review QC systems and procedures for adherence to regulatory compliance, quality improvements, efficiency and industry best practices. Provide compliance support and expertise for QC department.
  • Participate in QC compliance remediation plans and implementation.
  • Assists with the generation and/or revision of GMP documentation such as standard operating procedures.
  • Establish and execute laboratory audit readiness program to ensure a compliance ready state at all times in the laboratory.
  • Participates in QC internal audits as applicable.
  • Participate in site quality and process improvement initiatives. Represent QC Microbiology on site project teams.
  • Provide protocol generation and execution support for critical facility and utility qualifications and startups.

Education & Experience:

  • Minimum of a B.S. in a Life Sciences discipline
  • 8 years' experience within the biologic, biopharmaceutical, or regulated pharmaceutical Quality Control Laboratory
  • 3 years' experience in Quality / Compliance function
  • Experience with Environmental Monitoring Programs and microbial testing
  • Have the knowledge, and ability to apply basic scientific and regulatory principles to improve quality systems
  • Exposure to Lean Operational Excellence highly desirable
  • Experience working in electronic systems such as LIMS, EDMS, ERP desirable