Quality Associate I (TEMPORARY)
4 days ago
South Bend
Job DescriptionDescription: TEMPORARY, FULL-TIME Onsite Position 3 months - 6 months SUMMARY OF POSITION: The Quality Associate I is responsible for supporting day-to-day quality activities to ensure compliance with the Quality Management System, and procedures therein, and applicable regulatory requirements. ESSENTIAL FUNCTIONS, included but not limited to: • Partner with other departments, as needed to maintain product quality, drive and/or support continuous improvement, and ensure accurate and complete documentation., • Perform batch record review and release activities to ensure all documentation is complete , accurate, and compliant with established procedures and quality standards., • Perform release activities for materials, components, and finished products, etc., • Conduct various testing activities, including but not limited to quality control (QC), water testing, Total Organic Carbon (TOC), stability-related activities, and other routine quality testing as assigned., • Perform environmental monitoring (EM) activities as required., • Conduct calibration activities for equipment and instruments, including but not limited to weights, thermometers, thermocouples, and other measurement devices., • Assist with troubleshooting, root cause analysis, and continuous process improvement initiatives to enhance product quality and operational efficiency., • Support quality system activities related to CAPA (Corrective and Preventive Actions), NCR (Non-Conformance Reports), and planned deviations., • Provide validation support as needed, including execution and documentation assistance for validation protocols and reports., • Provide document control support as needed., • Assist with solution preparation activities as needed, following approved procedures and specification requirements., • Perform analysis and trending of Quality data as needed to support investigations, process monitoring, and continuous improvement., • Support internal and external audits, as required., • Adhere to current Good Manufacturing Practices (cGMP)., • Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc. OTHER FUNCTIONS: • Ensure compliance with safety regulations and procedures are implemented and followed; Maintain clean and safe work area., • Assist as needed in other areas of the company where training requirements have been completed., • Perform other duties as assigned. SUPERVISORY RESPONSIBILITIES: • None TRAVEL: • NoneRequirements: REQUIRED QUALIFICATIONS: • Legally authorized to work in the United States., • High School Diploma or its equivalent., • Proven quality management systems experience., • Previous experience of production/manufacturing and quality experience., • Knowledge of quality system processes such as batch record review, product release, CAPA, deviations, NCRs, document control and validation support., • Familiarity with statistical process control principles used to monitor and ensure the quality of the production process., • Ability to perform routine testing and interpret basic quality data., • Good understanding of laboratory equipment (e.g., pipettes, scales, pH meters)., • Experience using inspection and measurement tools such as calipers, micrometers, multimeters, or similar equipment, • General knowledge of biological and chemical concepts., • Familiarity with various standards and regulations such as ISO 9001, ISO 13485:2016, the Quality System Regulation (21 CFR Part 820) PREFERRED QUALIFICATIONS: • Associate or bachelor’s degree in Biology, Chemistry, Quality, Life Sciences, Engineering, or a related scientific/technical field., • Experience supporting quality audits, root cause analysis, or corrective actions, • Experience with document control, CAPA, and internal auditing., • Ability to analyze quality metrics and process data to identify improvement opportunities., • Direct laboratory experience in a biology, chemistry, or medical environment., • Experience with performing QC Testing, including assays, • Ability to operate laboratory equipment and understand complex testing protocols including analytical pipetting, enzyme assays, High-Performance Liquid Chromatography (HPLC), and electrophoresis., • General knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) or similar. BASIC SKILLS AND ABILITIES: • Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude., • Detail oriented with a high level of accuracy, efficiency, and accountability., • Possess a strong commitment to product quality and compliance., • Excellent organizational skills to meet goals and set priorities., • Ability to work independently and as a member of various teams and committees., • Proven ability to handle multiple projects and meet deadlines; work in a fast-paced environment., • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm, • Willingness to pivot between lab testing, documentation review, and floor support., • Ability to operate related office equipment, such as computers, calculator, and copier., • Able to work with small tools and electronic equipment to test and inspect., • Demonstrated ability to analyze and interpret information., • Ability to perform repetitive tasks and use laboratory/manufacturing instruments., • Working knowledge of Microsoft Excel, Word, and Outlook. REASONING ABILITIES: • Able to understand the basic reasoning and process of the scientific method., • Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form., • Ability to define problems, collect data, establish facts, and draw valid conclusions., • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. LANGUAGE SKILLS: • Ability to read and interpret work related documents, procedures, and manuals., • Ability to communicate effectively; good written and oral communication skills; ability to read, write, speak, and understand the English language. MATHEMATICAL SKILLS: • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals., • General knowledge of the metric system units (length, area, volume, capacity, mass, and weight) and U.S. equivalents. VISUAL ACUITY: • Close visual acuity to perform an activity such as preparing and analyzing data, transcribing, viewing a computer terminal, and reading. PHYSICAL DEMANDS: • Ability to work in a laboratory, manufacturing, or controlled environment., • Must be able to wear and work in personnel protective equipment (PPE) as required., • Light physical activity performing non-strenuous daily activities in a laboratory setting., • Ability to hear, understand, and distinguish speech., • Dexterity and coordination are necessary to handle small components., • Manual dexterity required for handling samples and performing precise calibrations., • Frequent repetitive motions that may include the wrists, hands and/or fingers to operate keyboard and mouse., • Frequently stand for prolonged periods of time., • Occasionally move about inside the facility to access office machinery, correspond with other departments, attend meetings/training, etc., • Frequently lift, carry, push, pull or otherwise move objects up to 10 pounds; occasionally carry, push, pull or otherwise move objects up to 25 pounds., • Occasionally required to climb or balance; squat, stoop, kneel, crouch, or crawl; and smell., • Occasionally reaching for items above and below desk level., • The ability to hear, understand, and distinguish speech., • Frequently communicate information and ideas with others to exchange information and understanding. Able to exchange accurate information in these situations. ENVIRONMENT CONDITIONS: • Well lit, heated/air-conditioned indoor laboratory setting with adequate ventilation., • The noise level in the work environment is moderate., • Frequent exposure to low temperatures in controlled refrigerators and/or freezers., • Occasional exposure to biohazards, fumes and other airborne particles.