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Quality Assurance 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 Assurance Associate plays a pivotal role in ensuring that all quality assurance activities are conducted efficiently and accurately. Under direct supervision, the associate supports daily tasks that are essential for maintaining and improving quality systems and adhering to client-specific procedures. Key responsibilities include document management, review of manufacturing batch records, quality control (QC) data, facilitating material releases, overseeing final product releases, and providing essential assistance to the Quality Management as needed.

Essential Functions and Responsibilities

Ensures that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical and commercial manufacturing.
Read, understand and follow all cGMP and cGTP documentation for Quality System Functions (SOPs,WIs,etc.)
Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical and commercial manufacturing.
Release raw material in ERP system as well as on paper.
Perform Accessioning of incoming Apheresis.
Review Batch record and disposition material of finished product to client.
Provides information for Out of Specification and deviations to investigator.
Performs line clearance prior to manufacturing operations begins.
Supports tech transfer activities.
Other duties as assigned.

Qualifications

BS or higher education degree in a scientifically related field
Experience in a biologics or biotechnology company (1-3 years)
Working knowledge and technical understanding of the aseptic manufacture of biologics preferred
Working knowledge of GMP and TCTP regulations
Experience in reviewing GMP/GCTP related documents (validations/qualifications reports, SOPs, etc)

Competencies/Candidate Profile

Relevant computer skills (Microsoft Office, Outlook)

Detail-oriented and organized

Analytical and problem-solving skills

Good written and oral communication skills

Ability to multi-task and be adaptable

Flexible and able to adapt to company growth and evolving responsibilities

Ability to work independently and with a team

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.

Minimum Required Training

cGMP Training and per company training requirement and as assigned

Supervisory Responsibilities

This job has no supervisory responsibilities.

Working Environment

Must have the ability to work in a team-oriented environment

Must be able to work during the weekend, holidays and as required by the company

May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids

Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen

Must have the ability to work with specialized equipment

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 physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully.

This role is sedentary. An individual may occasionally exert up to 30 pounds of force or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects. Sedentary entails sitting most of the time but may involve walking or standing for brief periods.

Must be able to gown up and go into the cleanroom.

Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have vision sufficient to read materials.

Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator.

Must have the ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in person, and on the telephone.

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.