Senior Quality Assurance Specialist

1 month ago

Louisville, United States Kelly Science, Engineering, Technology & Telecom Full time

Sr. Quality Assurance Specialist – Louisville, CO


Type: Contract (6 months – potential for extension/conversion)

Shift: M-F 8a-5p

Pay Rate: $46-$55/hr


Position Summary

We are seeking a Contract Quality Assurance (QA) Sr. Specialist to support deviation investigations related to Good Manufacturing Practice (GMP) operations at our state-of-the-art lentiviral vector development and manufacturing facility in Louisville, CO.


Responsibilities

  • Independent triage of potential non-conforming events to assess immediate corrections, need for subsequent deviation, and assign criticality in alignment with procedures.
  • Identification and assembly of cross-functional teams to achieve defined investigation milestones.
  • Utilization of appropriate root cause analysis tools commensurate with the level of investigational complexity and criticality.
  • Execution and management of investigations and deliverables within the electronic Quality Management System (eQMS) in accordance with defined requirements.
  • Timeline management of deviation corrections, corrective actions, and/or preventive actions.
  • Proactive communication and escalation of risks associated with investigations.
  • Providing investigation updates to site management and cross-functional business reviews.
  • Providing feedback and actively participating in deviation program metrics establishment and continuous improvement.
  • Potential to mentor/train investigators.
  • Potential to assist in developing investigation training material.
  • Potential to cross-train within the Quality Assurance organization to provide Quality oversight and support across other GxP tasks and programs.
  • Potential to support QC laboratory investigations.
  • Other duties, as assigned.


Qualifications

  • Bachelor’s degree in Engineering, Biochemistry, Molecular and Cellular Biology, Immunology, Biology, other life science, or related field.
  • Minimum of 8 years of work experience in an FDA regulated industry, or a similar combination of education and experience.
  • Previous experience performing and supporting deviation investigations in a cGMP biopharmaceutical manufacturing facility operations environment.
  • Proficient technical writing and communication skills with a proven ability to summarize complex, technical topics into easily digestible formats.
  • Excellent project management skills.
  • An understanding of quality management systems within an early-phase GMP environment.
  • Knowledge of relevant pharmaceutical regulations and regulatory guidance.
  • Understanding of risk management principles and philosophy within the quality system in support of first-in-human and Phase 1 products/programs.
  • Strong communication and organizational skills, and a passion for teamwork.
  • Ability to work effectively and efficiently in a collaborative manner across multiple functional areas with minimal supervision.


Preferred Qualifications

  • Experience performing QC laboratory investigations in a cGMP biopharmaceutical manufacturing facility operations environment.
  • Experience in cGMP cell and gene therapy manufacturing and/or testing facility.


Physical Requirements

  • Ability to gown aseptically and work in a Clean Room environment, if required.
  • Ability to work while gowned for extended periods of time, if required.
  • Ability to stand for extended periods of time to fulfill on-the-floor Quality duties, if required.
  • Use of laboratory equipment includes handling chemicals and biological materials.
  • Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs. and periodically lift up to 50 lbs.
  • Ability to work occasional nights and weekends as needed.

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