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: NoTravel: NoneEducation 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 SkillsMinimum 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.