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QA Specialist
2 months ago
Onsite role, Devens site
Work Schedule: Monday - Friday, Business Hours
To be considered for this role, candidate must have:
- Minimum of 1 year working in a GMP environment
- Experience using SAP
- Minimum 1-year experience performing visual inspection
- Experience performing review or verification work
PURPOSE AND SCOPE OF POSITION:
The Quality Assurance Incoming Material Disposition Specialist is responsible for supporting the incoming inspection and disposition of incoming materials such as consumables and raw materials at the Devens Cell Therapy Facility. Perform incoming inspection and review of the disposition deliverables to support disposition of materials and batches within the inventory management systems. Assure materials comply with all CLIENT policies, standards, Network & Global Standard Operating Procedures.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Experience in a laboratory, manufacturing, quality, or warehouse environment desired.
- Prior evidence of successful participation on work/study teams where combined contribution, collaboration, and time bound results are expected.
- Demonstrated proficiency in common computer tools such as word processing, spreadsheet, and web-based applications, as well as ERP solutions such as SAP.
- Previous work/academic experience where attention to detail and personal accountability were critical to success.
- Strong communication skills and the ability to follow written and verbal instructions.
EDUCATION AND EXPERIENCE
- B.S., in science, engineering, biochemistry, related discipline, or its equivalent
- 1-2 years of directly relevant experience in a regulated cGMP environment.
- Any combination of education, experience, and military service in line with recommendations above will be considered.
WORKING CONDITIONS:
- Work is generally performed seated in a Warehouse condition but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
- Work in a cGMP laboratory and/or manufacturing environment following techniques which require one to maintain a high attention to detail. Properly use Personal Protective Equipment (PPE), gowning for restricted areas, aseptic processing, handling chemicals, and work in a general office environment.
