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:
- 2nd shift OTF support or weekends.
- Provide QA on-the-floor support to manufacturing, packaging, and warehouse operations to ensure compliance with cGMP and site procedures.
- Perform real-time line checks, AQL inspections, and verification of critical steps in production processes.
- Review executed batch records, logbooks, and other production documentation for completeness, accuracy, and compliance prior to disposition.
- Assist in product disposition by preparing QA summaries, verifying data integrity, and ensuring all release criteria are met.
- Support the initiation and review of Change Controls, deviations, ensuring thorough root cause analysis and appropriate corrective and preventive actions (CAPA).
- Collaborate with manufacturing, quality control, and MSAT teams to resolve issues identified during production or review.
- Participate in quality investigations, and continuous improvement initiatives.
- Ensure adherence to all safety and environmental requirements.
- Maintain current knowledge of applicable cGMP regulations and company quality policies.
- Perform final review of room, equipment, and facility records and associated support systems to release areas for cGMP operations.
- Perform review of documentation to determine release status. Approve material for release or nonconformance investigation.
- Assist in internal compliance and external (supplier) audits as assigned.
- Able to support 24/7 process operations and shift schedule.
Requirements:
- Education: Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, or related field; 0-2 years of related experience and/or training in biotech, or related regulated industry.
- Previous QA, QC, or manufacturing experience preferred.
Knowledge / Skills / Abilities:
- Strong attention to detail, effective communication, teamwork, and organizational skills Other: Willingness to work in production areas and flexible shifts as needed.
- Previous and substantial GMP experience is required, as is prior knowledge of word processing, database management, and record-keeping.
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.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Miltenyi Biotec San Jose, California, USA Office
2825 N 1st St, San Jose, CA, United States, 95134
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