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Experience level: Mid-senior Experience required: 6 Years Education level: Bachelors degree Job function: Quality Control Industry: Biotechnology Compensation: View salary Total position: 1 Visa : Only US citizens and Greencard holders
JOB DESCRIPTION:
At our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company. Leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance.
ESSENTIAL FUNCTIONS AND RESPONSIBILITES
Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations.
Drive investigations to true root cause using appropriate investigation tools.
Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets.
Define and implement effective preventative actions to prevent recurrence.
Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates.
Collaborate with cross-functional teams to develop and track CAPA plans.
Identify and create appropriate trending rules that trigger corrective actions.
Analyze process data and evaluate trends to identify major improvement opportunities.
Effectively utilize change management approach.
Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process.
Champion CAPA plans and implementation.
Provide communication plan for on-going deviations & CAPAs.
Effectively create and communicate CAPA plan to responsible parties.
Oversee timely completion of deviations, CAPAs, and Change Controls as necessary.
Ability to abide by quality standards.
QUALIFICATIONS:
Bachelor of Science in a Quality / Process related field.
Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma.
Root cause analysis experience in pharmaceutical or FDA regulated operation preferred.
Experience using e-Quality Management Systems preferred.
Relevant IT skills (able to work with Visio, Microsoft Project and Excel).
Competencies/Candidate Profile
Ability to think strategically and tactically (detail-oriented)
Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
Analytical and problem-solving skills
Strong written and oral communication skills
Flexible and able to adapt to company growth and evolving responsibilities
Integrity, accountability and strong dedication to regulatory compliance
Continuous improvement mindset.
Ability to work effectively as a team and independently.
Working Environment
While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen.
The noise level in the work environment is moderately noisy.
Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.
While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear. The employee is regularly required to climb or balance; stoop, kneel, or crouch. The employee is frequently required to lift and/or move up to 30 pounds.
Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Shift Details:
Monday-Friday, Day Shift (8:00AM-4:30 PM)
ESR Healthcare
