QS Associate - Line Auditor
: Job Details :

Description Essential Functions of the Job: • Manage the Annual Drug Product Review (ADPR) process. • Support the Change Control process including initiation, approvals, and closure. • Initiate and participate in investigations (including Laboratory Investigations). • Manage the CAPA process including initiation, closure and performance of Effectiveness Checks. • Ensure compliance to cGMP standards in the Manufacturing and Packaging areas. • Perform Production line inspections. • Issue and perform review of logbooks and notebooks. Perform daily calibration checks of packaging equipment. • Perform daily checks of temperature monitoring units and notification to management/facilities of excursions. • Reconcile staged components with approved bill of materials. • Sample, inspect, and approve customer and vendor components. • Sample, identify, and submit customer and vendor raw materials to the lab for testing. • Perform all required testing at established frequency. • Record all test and inspection results immediately and accurately. • Compile, organize, and review documentation from customers, Manufacturing, Packaging, and Laboratories. • Draft, review and approve component MARS, manufacturing batch records, and packaging batch records. • Review and approve batch records for release of customer product. • Resolve any documentation discrepancies related to assigned tasks. • Update paper and electronic records. • File and archive documentation. Perform other duties as assigned. Minimum Requirements of the Job: • Comply with all company policies, SOP's, current Good Manufacturing Practices and other relevant regulatory requirements. • Maintain training at or above 90% of assigned curriculum. • Possess Good Documentation Practices. • Possess a working knowledge of MS Office applications (word, excel, etc...) • Attention to detail. • Ability to work individually and in groups. • Interpersonal skills. • Ability to perform basic math skills. • Ability to read, write and understand English. • Effective communication skills. • Meet deadlines as assigned. • Ability to read, inspect and match batch codes. • Possess a working knowledge with the use of balances, torque meters, vacuum/seal strength testers, and computer. • Demonstrate the ability to be flexible to changing requirements and duties of the position. Physical Requirements: • Ability to lift up to 40 lbs. • Walking within the confines of the facility. • Standing up to 80% of designated shift time. • Good hearing (ability to hear alarms, ringing). • Ability to bend/kneel to verify components. • Ability to see colors and good sense of smell. • Peripheral Vision. Supervisory Responsibilities: No Travel: None Education and/or Experience: The QA Associate I must have a college degree and 0-2 years of Quality Control/Assurance experience in related field and LIMS experience. The QA Associate II must have a college degree, 2 plus years of Quality Control/Assurance experience in a related field and LIMS experience. #INDOTHER2024 Required Skills Minimum Requirements of the Job: • Comply with all company policies, SOP's, current Good Manufacturing Practices and other relevant regulatory requirements. • Maintain training at or above 90% of assigned curriculum. • Possess Good Documentation Practices. • Possess a working knowledge of MS Office applications (word, excel, etc...) • Attention to detail. • Ability to work individually and in groups. • Interpersonal skills. • Ability to perform basic math skills. • Ability to read, write and understand English. • Effective communication skills. • Meet deadlines as assigned. • Ability to read, inspect and match batch codes. • Possess a working knowledge with the use of balances, torque meters, vacuum/seal strength testers, and computer. • Demonstrate the ability to be flexible to changing requirements and duties of the position.