QA Technician II

Work Schedule

Environmental Conditions

Job Description

Schedule: Monday-Friday 8am to 4:30pm

The QA Technician will review batch records, identify documentation errors, and coordinate with Operations to resolve errors or raise issues as part of the quality assessment of products. This person will also be responsible for filing and document retrieval as needed. The QA Technician requires excellent attention to detail, organizational skills and interpersonal skills to ensure timely and accurate evaluation of documentation.
Key Responsibilities:
• Review production batch documentation for compliance with cGMP good documentation requirements.
• Communicate effectively and coordinate tasks with Manufacturing and Quality Control to facilitate timely release of products.
• Process 100% inspection rework activities and stock adjustments.
• Track and trend functional metrics.
• Support compliance initiatives and Regulatory and Customer Audits.
• Assist with continuous improvement projects and participate in lean activities.
Minimum Requirements:
• High School Diploma or equivalent.
• Working knowledge of various computer software programs such as Teams and Excel.
• Self Motivated and able to work in a team environment
• Able to work in filing room environment and lift 50 lbs for document archival, as needed

Preferred Requirements:
• 1+ years of experience in QA, QC, or manufacturing within a regulated environment such as medical device, pharmaceutical, or food manufacturing.
• Background in Medical device, cGMP, or ISO certified environment.
• Data entry skills and familiarity with inventory management systems such as SAP.
• Proven ability to work effectively as a member of a cross-functional team.
Physical Requirements:
• Work requires recurring bending, crouching, stretching, or reaching. Or may frequently operate equipment, including keyboard with mouse and must walk, sit or stand immobile for prolonged periods. Usually in a comfortable environment but does require time on production floor to collect documentation. Frequent need to distinguish among or interpret a variety of sensory inputs that require attention to decode and identify. (e.g., reading handwritten values, reviewing balance sheets).