Regenerative Medicine Laboratory Specialist

2 days ago


Mountain View, California, United States Minaris Regenerative Medicine Full time

Minaris Regenerative Medicine offers a competitive salary of $85,000 - $105,000 per year for the QC Analytical Associate II role.

 

About Minaris Regenerative Medicine

We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. Our vision is creating future cell therapy miracles together.

 

Job Description

The Quality Control Analytical Associate II serves as a support role to clinical and commercial production. The primary responsibilities of this position include assisting with process check point, stability, and release analytical testing to ensure that quality standards are upheld for all products produced at the facility.


Main Responsibilities:

Perform accurate execution of company and/or client test methods and procedures of cellular products to ensure safety and efficacy
Maintain equipment, monitor its performance, and troubleshoot issues
Train other Quality Control technicians and maintain training records
Test, document, and report results for products or materials following company and/or client procedures under cGMP and GTP guidelines
Participate in managing QC materials and supplies
Conduct equipment and method qualification/validation activities as needed
Prepare reagents and media
Provide input on troubleshooting malfunctioning equipment
Investigate out-of-specification, out-of-trend, aberrant, and/or non-conforming test results
Initiate deviation reports with supervisor input
Implement corrective actions as necessary
Document shipping test samples to contract laboratories for testing
Complete documentation according to written Standard Operating Procedures in accordance with Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
Communicate effectively with co-workers, departments, management, and clients
Serve as lead and/or co-lead for client projects when required
 

Qualifications:

Bachelor's degree in a science-related field required
2-5 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry
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
 

Competencies:

Proficient with Microsoft Office software
Strong written and oral communication skills
Presentational skills a plus
Candidate must be detail-oriented, able to multitask, work in a team environment, and adapt to company growth and evolving responsibilities
 

Benefits:

This role is contingent on sufficient training and execution of assays within 90 days of start date
Must be physically capable to work in a laboratory environment for an extended period
Must be able to stand, walk, sit, bend, stretch, use hands to finger, handle, or feel; reach with hands and arms; and talk or hear
Shifts may include weekend, holiday, and overtime work as required by the company
 

Disclaimer:

Please note that 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.



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