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Senior Quality Assurance Specialist
1 month 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.
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