Quality Assurance Specialist II PC 821

Miltenyi Biomedicine

29d • Onsite

About The Position

This position supports daily Quality Assurance activities at the Auburn site,
including material release, documentation and archival management. The role
ensures compliance with GMP, GDP, and company procedures while contributing to
site inspection readiness and long-term QA system development.

Requirements

• Bachelor's Degree in biological or life sciences, engineering; 2–4 years of experience in Quality Assurance, GMP manufacturing, or GMP distribution.
• Working knowledge of GMP/GDP principles and basic understanding of ISO 9001 or ISO 13485 systems.
• Experience supporting QA activities such as documentation review, deviations, or product release.
• Exposure to internal or customer audits and willingness to learn audit preparation and response coordination.
• Familiarity with ENNOV, SAP, or similar eQMS tools preferred.
• Good written and oral communication skills.
• Excel and SAP ERP Systems
• Ability to prioritize and manage multiple tasks

Nice To Haves

• Familiarity with ENNOV, SAP, or similar eQMS tools preferred.

Responsibilities

• Provide on-site QA support by monitoring daily operations for compliance and promptly reporting any quality concerns or high-risk issues to management.
• Assist with maintaining QA systems such as Deviation, CAPA, Change Control, Supplier Qualification, and Document Control. Support SOP revisions, ensure procedures are followed, and participate in staff training as directed.
• Prepare and review documentation for accuracy, completeness, and compliance with GMP, GDP, and ISO standards. Escalate issues or inconsistencies to QA management for further evaluation.
• Support internal and external audits by organizing evidence, coordinating assigned responses, and tracking timely completion of follow-up actions within QA systems to maintain inspection readiness.
• Perform on-floor GDP checks and self-inspections to verify compliance and identify improvement opportunities.
• Execute day-to-day tasks of the Material Release Program, ensuring all required documentation is complete, accurate, and compliant with GMP, GDP, and company procedures. Escalate any discrepancies or release holds to QA leadership for final review and disposition.
• Execute day-to-day tasks of the Quality Documentation and Archival Program, including document issuance, reconciliation, scanning, and retrieval to ensure inspection readiness.
• Collaborate with cross-functional teams and other sites to support harmonization efforts, validation activities, and continuous improvement initiatives.
• Support a developing site environment by performing core QA tasks and adapting to evolving systems and workflows. Demonstrate flexibility, attention to detail, and a willingness to learn as processes mature.
• Continue developing proficiency toward independent system ownership and advanced QA review.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level