JOB DESCRIPTION:

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.

The Quality Control Analytical Associate III serves as a support role to clinical and commercial production. The QC Analytical Associate III will assist with process check point, stability, and release analytical testing to ensure that quality standards are upheld for all products produced at the facility.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Under the direction of the Manager, QC Analytical, responsibilities of the QC Analytical Associate III will include but are not limited to:
• Performs accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations
• Performs maintenance, monitoring, and troubleshooting of pertinent equipment
• Performs and assists in the training of other Quality Control Analytical Associates
• Maintains training records and coordinates records retention with Document Control and Training groups
• Tests, documents, and reports results for products or materials following company and/or client procedures following CGMP and/or GTP guidelines
• Performs state proficiency testing and/or client proficiency testing under direct supervision as applicable
• Participates in managing QC materials and supplies
• Performs and assists in equipment and method qualification/validation activities as needed
• Performs reagent and media preparation
• Provides input based on level of knowledge and experience with troubleshooting malfunctioning equipment
• Leads investigations for out-of-specification, out-of-trend, aberrant, and/or non-conforming test results
• Determines root causes and implements intelligent corrective and preventive actions (CAPAs) and monitors CAPA effectiveness
• Initiates, investigates, and prepares deviation reports with input from assigned supervisor
• Brainstorms and implements corrective and preventive actions, as and when applicable
• Documents training and execution of shipping test samples to contract laboratories for testing
• Completes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
• Ensures timely issuance, review, and approval of Certificate of Analysis, alongside timely closures of batch records, deviations, and CAPA
• Initiates, assesses, approves, tracks, and trends deviations, Change Controls and CAPAs
• Communicates effectively with other co-workers, departments, management and clients
• Eventually serves as a lead and/or co-lead for client projects
• Manages and drives resolution of quality issues with clients, collaborators, and internal personnel
• Makes informed and independent decisions on complex issues in collaboration with key stakeholders and alignment with company policies.
• Manages completion of document changes and maintains the internal QC change control system
• Applies expertise of compliance requirements and therefore maintains an inspection-ready state laboratory
• Participates as subject matter expert during audits/inspections
• Works with internal departments and outside vendors, collaborators, and partners effectively for meeting projects timelines and commitments
• Additional tasks as assigned

QUALIFICATIONS

• BA/BS in a science or relevant field required
• MS is preferred
• Prior cGMP experience required
• Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must
• Prior industrial experience in cell count methodologies preferred
• Prior academic and/or industrial cell therapeutic experience preferred
• Minimum 4-6 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry

Competencies/Candidate Profile

• Proficient with computer software such as
• Microsoft Office
• Visio
• Strong written and oral communication skills
• Strong presentational skills preferred
• Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities

Minimum Required Training

Employment as a QC Analytical Associate III is contingent on the ability to be able to document sufficient training and execution of assays effectively within 90 days of start date.

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. Must have the ability to work in a team-oriented environment and with clients
• Must be able to work during the weekend, holidays, and as required by the company
• Must be able to handle the standard/moderate noise of the manufacturing facility

Physical Requirements

• The QC Analytical Associate III must be able to work in a laboratory environment for an extended period.
• Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear

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.