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Your Role: This position is primarily responsible for providing Quality Assurance support for manufacturing operations to ensure compliance with cGMP, internal procedures, and regulatory requirements. This role performs …
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San Jose, California, United States • On-site
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Provide on-the-floor Quality Assurance support for manufacturing, packaging, and warehouse operations to ensure cGMP compliance. Responsibilities include reviewing batch records, managing deviations and CAPAs, and assisting in product disposition.
Requires a Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, or a related field with 0-2 years of experience in a regulated industry. Candidates must be willing to work flexible shifts, including 2nd shift and weekends, in a cleanroom environment.
Your Role:
This position is primarily responsible for providing Quality Assurance support for manufacturing operations to ensure compliance with cGMP, internal procedures, and regulatory requirements. This role performs on-the-floor QA oversight, batch record review, product disposition activities, and supports the investigation and review of deviations and other quality events.
Essential Duties and Responsibilities:
Requirements:
Knowledge / Skills / Abilities:
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 35 pounds. Visual acuity required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus.
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 controlled biological manufacturing cleanroom and microbiology laboratory, using such equipment as particle counters, air samplers, biosafety cabinets, incubators, plate readers and computers. While performing the duties of this job, the employee is exposed to viruses and bacteria. Employees entering the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.
The hiring range for this position is expected to fall between $80,591 - $94,903/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.
The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company’s good faith and reasonable estimate 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, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.
Miltenyi Biotec is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
Miltenyi Biotec, Inc. participates in E-Verify.
The Company will provide reasonable accommodations to candidates and employees, unless doing so would impose an undue hardship on the Company, in accordance with applicable law.
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.
For over 35 years, we have been developing cutting-edge science and technology to empower biomedical research and personalized medicine. We combine excellence from more than 60 disciplines in natural sciences, engineering, and informatics to make a significant contribution to biomedical sciences. We encourage a creative working environment driven by pioneering spirit – to seek new horizons – boldly envisioning the future and turning it into reality. Today, more than 5,000 experts from over 75 countries contribute to our sustainable success.
Offices: Friedrich-Ebert-Straße 68, Bergisch Gladbach, North Rhine-Westphalia 51429, DE · 2303 Lindbergh Street, Auburn, CA 95602, US · Robert-Koch-Str. 1, Teterow, Mecklenburg-Western Pomerania 17166, DE · Astastraße 14, Bielefeld, North Rhine-Westphalia 33617, DE · Bertha-von-Suttner-Str. 5, Göttingen, Lower Saxony 37085, DE
