Job Title:

Quality Assurance Technician I

Reports To:

Quality Assurance Manager

Direct Reports:

Not Applicable

Emergency / Absentee Backup:

Quality Assurance (Technician I)

Job Summary:

The Quality Assurance Technician I is directly responsible for filing, storage, distribution and organization of electronic and paper-based regulatory related documents. The QA Technician I is responsible for the inspection and release of processes and materials for use in GMP activity.

Essential Duties and Responsibilities:

• Scans/Files Quality Assurance related documentation as applicable.
• Inputs, reviews and analyzes specific batch and process data into various spreadsheets for product evaluation.
• Obtains requested documents as necessary in support of an audit, department or customer request.
• Assists in finding, copying, and filing paperwork needed for completion of various records.
• Assists with the maintenance of Temperature and Humidity Monitoring Program supporting documentation.
• Performs Temperature and Humidity Monitoring Assessments monthly.
• Assists with the creation of various analytical tools, such as statistical analysis, to evaluate and interpret data.
• Coordinates change control approval process and completes implementation requirements as instructed by Quality Assurance Management.
• Performs Finished Good Inspection and/or QA Approval prior to Finished Good Shipments when not involved in product labeling activities.
• Issues Certificate of Analysis for Finished Goods Shipments.
• Creates Certificate of Analysis
• Approval of Raw Material within ERP system.
• Places incoming components and raw material on Hold.
• Performs inspections for incoming components for disposition.
• Ensures Good Documentation Practices are followed on all submitted documentation and log books.
• Performs daily walk throughs of the facility to ensure all BioSpectra policies and procedures are being followed.
• Performs in process review of manufacturing documentation including logbooks, batch records, raw material usage sheets, etc.
• Identifies documentation practice errors or concerns and immediately communicates the requirements for correction to specific personnel.
• Identifies process or system deviations in real-time and communicates findings to Quality Assurance Management.
• Performs Discrepancy investigations and provides investigation report to Quality Assurance Management.
• Supports CAPA commitment closure as instructed by Quality Assurance Management.
• Inspects process rooms to ensure each meets cleaning and use requirements before the start of a batch record.
• Performs verifications in manufacturing processes as applicable based on training.
• Assists with labeling of material and or out going shipments.
• Formats documents in accordance with BioSpectra policies.
• Other duties may be assigned as deemed appropriate by management.

Qualifications:

• 2-year Associates Degree or approved equivalent experience in a cGMP environment
• Understanding of cGMP & ICH-Q7
• Knowledge of relevant software applications including MS Office and Minitab
• Knowledge of office systems and procedures
• Organized, Thorough, Neat
• Must be able to read, write, speak, and understand English
• Confidentiality

Physical Requirements:

• Lift up to 20 lbs. occasionally
• Prolonged periods sitting at a desk and working on a computer
• Repeating motion that may include wrists, hands, and fingers

Work Hours:

• Non-Exempt Position
• Sunday-Thursday or Tuesday to Saturday
• 2pm -10:30pm
• Ability and willingness to work from all BioSpectra facilities