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Quality Assurance Technician I

2 months ago

Bloomington, Indiana, United States Greiner Full time

Your Challenge

Location: Monroe, NC

Responsibilities:

• Execute quality control testing and assessments in accordance with established protocols.

• Conduct Incoming Goods Inspection following valid procedures.

• Prepare solutions and equipment for production based on required Technical Procedures (TPs) and Standard Operating Procedures (SOPs).

• Maintain cleanliness and sanitation of laboratory and quality control areas.

• Perform quality control inspections on the manufacturing floor.

• Generate a Quality Incident Report (QIR) for any non-conforming products.

• Analyze non-conforming products to address QIR issues and investigate returned items through the complaint processing system.

• Carry out equipment calibration.

• Conduct routine inventory checks for laboratory supplies (e.g., chemicals, materials).

• Assist in maintaining the inventory database and SAP inventory system.

• Help in ordering chemicals and laboratory supplies.

• Perform additional duties as assigned.

Authority:

• Evaluate products during production in line with valid Quality Management Inspection (QMI) documents.

• Restrict non-conforming products as per appropriate QMI documentation.

• Authorize product release according to valid QMI documents.

• Approve incoming goods based on valid Certificates of Analysis.

• Sanction sterilization processes.

• Authorize the release of solutions.

• Execute SAP transactions to hold and release products.

Your Profile

Job Requirements:

• High school diploma or equivalent; a degree is preferred along with at least one year of relevant experience.

• Experience in the medical device, pharmaceutical, or regulated industries is preferred.

• Strong communication and writing skills are essential.

• Must have completed a QC training program for a minimum of three months.

• Successful completion of a pre-employment assessment is required.

• Basic computer skills and proficiency in MS Office are necessary.

Physical Requirements:

• Ability to stand and walk for extended periods (up to 8-12 hours).

• Capability to lift items weighing up to 70 lbs.

• Adequate vision to perform detailed quality inspections as outlined in SOPs and TPs.