QA Associate I

1 month ago

Mountain View, United States Minaris Regenerative Medicine Full time
Job DescriptionJob Description

Quality Assurance 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.


Responsible to perform Quality Assurance activities under direct supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, review of QC data, material releases and final product releases as well as assisting Quality management with department needs.

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.
Perform raw material inspections and raw material release according to SOPs and in compliance with all regulatory standards.
Issuance of batch records; review of media batch records.
Issue and maintain all cGMP and cGTP documentation, including but not limited to logbooks, training binders.
Perform Accessioning of incoming Apheresis.
Other duties as assigned.

Qualifications

BS degree in a scientifically related field
Some experience in a biologics or biotechnology company preferred
Working knowledge and technical understanding of the aseptic manufacture of biologics preferred
Working knowledge of cGMP and cGTP regulations

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 To Be Completed within the first 90 Days of hire

GXP training
SOP & WI training
Safety Training

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

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, 8:00 AM - 5:00PM, and as needed per business demand.

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