What are the responsibilities and job description for the QC Analytical Associate III position at Minaris Regenerative Medicine?
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 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
Quality Requirements
Build Quality into all aspects of your work by maintaining compliance to all quality requirements.
Ensure compliance with 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 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.
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
Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
Sunday- Thursday (6 am - 2:30 pm)
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
Quality Requirements
Build Quality into all aspects of your work by maintaining compliance to all quality requirements.
Ensure compliance with 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 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.
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
Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
Sunday- Thursday (6 am - 2:30 pm)
