Job Description:
• 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)