QC Analytical Associate II

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 II serves as a support role to clinical and commercial production. The QC Analytical Associate II 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 II 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. Performs maintenance of

laboratory equipment including routine start-ups, shutdowns.

Tests, documents, and reports results for products or materials following company and/or client procedures

following CGMP and/or GTP guidelines.

Performs client proficiency testing under direct supervision as applicable.

Maintains and inventories QC materials and laboratory supplies.

Organizes the lab and put supplies away in a net and organized manner.

Perform cleanings of laboratory equipment (incubators, refrigerators, freezers, etc.,) per SOP.

Performs and assists in equipment and method qualification/validation activities as needed.

Crosstrain in methods for multiple (up to 4) clients to increase efficiency in the lab for all client projects.

Upload data in real time on to shared drive or client Share Point sites.

Performs reagent and media preparation.

Respond to all QC equipment alarms in view Linc Alarm Report system.

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

Document’s 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).

Communicates effectively with other co-workers, departments, management and clients

Performs and assists in the training of other Quality Control technicians

Maintains training records and coordinates records retention with Document Control and Training groups.

Manages QC materials and supplies.

Ensures timely issuance, review, and approval of Certificate of Analysis, alongside timely closures of batch

records, deviations, and CAPA.

Initiates, assesses, tracks, and trends deviations, Change Controls and CAPAs.

Applies expertise of compliance requirements and therefore maintains an inspection-ready state laboratory.

Participates as subject matter expert during audits/inspections.

Serves as a lead and/or co-lead for one or more client projects. Lead responsibilities include leading the

QC meeting with the client representing Minaris with all concerns addressed with the assistance of QC

management.

Track program status via client tracker.

Additional tasks as assigned.

Qualifications
 
BA/BS in a science or relevant field required
Prior cGMP experience required
Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment preferred
Prior industrial experience in cell count methodologies preferred
Prior academic and/or industrial cell therapeutic experience preferred
Minimum 2-5 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 global 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 II 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

This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. 

Physical Requirements
 
The QC Analytical Associate II 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

Must be capable of moving, sitting, stretching, stooping, using hands and fingers, reaching with hands and arms, talking and exchanging information, and vision sufficient to read materials. 

The employee is frequently required to lift, move, or carry up to 50 pounds and occasionally move tanks up to 300 pounds (with assistance).

Heavy cryo-gloves must be used when working with liquid nitrogen 

Must be able to exchange information in person, on the telephone, and to make presentations. 

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.