Quality Assurance Specialist I *PC 596

Description

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time.

One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry - our contract development and manufacturing organization (CDMO).

As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products.

This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale.

Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.

Quality Assurance Specialist I

San Jose, CA

Your Tasks :

This position will support the daily Quality Assurance activities related to GMP manufacturing for cell therapy products.

This position will also support the implementation of quality systems in compliance with cGMPs and other Company policies.

Essential Duties and Responsibilities :

• Perform compliance review of batch production records for GMP manufactured clinical products including QC release testing, labeling, packaging, and supporting documentation.
• Support routine in-phase inspections during clinical product manufacturing including but not limited to line clearances, product inspections, and packaging operations.
• Support receipt, inspection and release of raw materials and components.
• Assist with deviation investigations and resolution of minor discrepancies relating to manufactured products and raw materials.
• Review equipment documentation such as activity logs, chart recorders, calibration records, IQ / OQ / PQ, etc.
• Support the development, implementation and maintenance of QA databases and other electronic systems.
• Develop, update and / or review standard operating procedures, batch production records, etc.
• Support Document Control activities such as document processing, issuance and archival.
• Conduct training on Quality systems as needed.
• Cross train on other Quality functions such as Quality Control as needed.
• Assist in internal and external audits, third party audits and regulatory inspections.
• Other duties as assigned.

Requirements :

Bachelor's Degree in Life science or equivalent; 2 - 5 years of direct QA experience related to GMP Manufacturing in the biotechnology or pharmaceutical industry;

Or equivalent combination of education and experience.

• Strong knowledge of cGMPs.
• Excellent oral and written communication skills.
• Experience in cell-based therapeutics or biopharmaceuticals preferred.

Physical Demands :

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

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk;

use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch.

The employee must occasionally lift and / or move up to 20 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment :

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers.

While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues.

Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment. The noise level in the work environment is usually moderate.

As a global team of over 3,000 diverse innovators, we are united by a shared vision to advance research and improve patient care worldwide.

Our mission transcends mere scientific discovery; we are on a quest to unravel the complexities of biology and transform them into tangible solutions that propel research to unprecedented heights.

These developments have led to cutting-edge cell and gene therapies - transformative methods that mobilize the body's own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions.

Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow. Here, you will contribute to work that is breaking barriers, blending the wonders of biological discovery with the pursuit of well-being for all.

Every day presents a chance to make a tangible impact and play a key role in accelerating the journey of research from the lab to the market.

Join Miltenyi Biotec and immerse yourself in an environment where your efforts are significant, your contributions are valued, and your work truly matters.

The anticipated base salary range has been established at $79,400 - $107,500 / year. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialization, skills, abilities, and training.

The above salary range represents the Company's good faith and reasonable estimate of the range of possible compensation at the time of posting.

In addition to your salary, the Company offers a comprehensive benefits package including health, vision, and dental insurance, plus a 401(k) plan.

All benefits are subject to eligibility requirements. Certain positions are eligible for additional forms of compensation such as bonuses or commissions.

Miltenyi Biotec, Inc. is an EO Employer - M / F / Veteran / Disability / Sexual Orientation / Gender Identity.

Miltenyi Biotec, Inc. participates in E-Verify.