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Miltenyi Biotec · 3 hours ago

Quality Assurance Specialist I (Swing Shift) *PC 1554

Gaithersburg, MD

Full-time

Onsite

New Grad, Entry Level

$72K/yr - $79K/yr

0+ years exp

Miltenyi Biotec is a leader in biomedical research and manufacturing, committed to making a real impact through innovative solutions. The Quality Assurance Specialist I is responsible for ensuring compliance with quality standards in manufacturing operations, providing oversight and support to maintain cGMP regulations and internal procedures.

BioinformaticsBiotechnologyHealth CareMedical

H1B Sponsor Likely

Responsibilities

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 review of 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

Qualification

CGMP knowledgeQuality Assurance experienceBatch record reviewEffective communicationAttention to detailWord processingDatabase managementRecord-keepingTeamworkOrganizational skills

Required

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

Understanding of cGMP, regulatory expectations

Strong attention to detail, effective communication, teamwork, and organizational skills

Willingness to work in production areas and flexible shifts as needed

Previous and substantial GMP experience is required

Prior knowledge of word processing, database management, and record-keeping

Preferred

Previous QA, QC, or manufacturing experience preferred

Benefits

Health, vision, and dental insurance

401(k) plan

Additional compensation such as bonuses or commissions

Company

Miltenyi Biotec

Glassdoor3.7

Design, development, manufacture, integration of products empowering the advancement of biomedical research and enable cell and gene therapy

Founded in 1989

Bergisch Gladbach, Nordrhein-Westfalen, DEU

1001-5000 employees

http://www.miltenyibiotec.com

H1B Sponsorship

Miltenyi Biotec has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2023 (1)

2022 (1)

2020 (2)