QC Analytical Associate I

Quality Control Analytical Associate I

At Minaris Regenerative Medicine 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 serves as a support role to clinical and commercial production. The QC Analytical Associate 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 I will include but are not limited to:

Performs the 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
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
Investigates out-of-specification, out-of-trend, aberrant, and/or non-conforming test results
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 and equipment 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).
Communicates effectively with other co-workers, departments, management and clients.
Additional tasks as assigned.

Qualifications

BA/BS in a science or relevant field required
Prior cGMP experience preferred
Prior academic and/or industrial cell therapeutic experience preferred
Minimum 0-2 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

Quality Requirements

Build Quality into all aspects of your work by maintaining compliance to all quality requirements.

Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).

Attend all required Quality & Compliance training at the specified interval.

Supervisory Responsibility

N/A

Minimum Required Training

Employment as a QC Analytical Associate I 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 I 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

Direct reports

N/A

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.