Quality Assurance Specialist Jobs

POSITION SUMMARY:

The primary role of the QA Specialist is to disposition raw materials for GMP use ensuring conformance to specifications, compliance with Quality Assurance (QA) policies and procedures, cGMPs and SOPs.

Essential Duties and Responsibilities:

• Monitors area operations and notifies Area and Quality Management of any observed non-compliance
• Perform sampling, as required, using electronic equipment
• Work independently with minimal supervision and partner with cross-functional departments (e.g. Warehouse & Logistics, QC, Procurement, Manufacturing and Manufacturing Support) and external suppliers ensuring timely disposition of raw materials
• Support document revisions, deviation investigations, CAPA, Change Control
• Inspect raw materials, review material specifications, supplier documentation and analytical results
• Communicate effectively, provide and receive feedback diplomatically, collaborate with stakeholders to resolve issues
• Participate in GMP Self-Assessments and or external audits/inspections
• Following safety rules, company policies, SOPs, cGMP guidelines and compliance to CFR Title 21 Parts 10, 210 and 211
• Ability to prioritize workload and adapt within a dynamic environment
• Performs other QA Operational duties as assigned including but not limited to: batch record review, lot preparation for disposition, projects, archiving, changeover verification, QA AQL vial inspection, QA Document Control support.
• Continuous improvement by identifying efficiencies and resolving gaps in system and process

REQUIREMENTS:

Minimum Education/Experience

• Understanding basic cGMP is also preferable.
• Bachelor’s degree (or equivalent), preferably in scientific discipline or a health-related field.
• 1+ years relevant industry experience is preferable

Other Qualifications

• And be resourceful.
• Strategic agility, strong critical and logical thinking with ability to analyze problems
• Strong ability to prioritize, multi-task, and work in an evolving environment.
• Able to work effectively in a fast-paced and dynamic environment.
• Excellent presentation and written/verbal communication skills.
• Strong organizational skills and attention to detail.
• Self-motivated, self-disciplined and able to function independently as well as part of a team.
• Computer proficiency (MS Word, Excel, PowerPoint).