QA Technician

Job Description

Job Summary:

• 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.

Duties and 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).