Senior Quality Assurance Specialist
1 week ago
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.
For Immediate Consideration - Apply Today
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