Production Lab Tech
5 days ago
Saint Louis
Job DescriptionJob Title: Production Lab Tech Location: St. Louis, MO 63103 Duration:12 Months role (Temp to hire potential) Hours: Training will be 7 am - 3:30 pm. Afterwards 9 am – 5 pm Preferred Skills: SAP, Aseptic techniques, and product experience Bachelor’s degree preferred, associate’s degree acceptable. Primary Objective of Position: • Under direct supervision, the Production Lab Tech II performs various technical-level duties in the areas of manufacturing, filling, labeling, packing, shipping, and other duties as assigned in a laboratory/manufacturing environment adhering to standard operating procedures involving basic laboratory techniques, calculations, materials measurements, operation of laboratory equipment and record keeping as necessary. Essential Functions and Abilities: • Perform area clearance tasks, maintain separation of product, • Perform standard and new operating procedures, • Collect and record data on documents and batch records where required, • Utilize computer hardware and software for data entry and record keeping where required, • Ensure compliance with all Quality and Regulatory specifications, • Support process improvement through identification and reporting of areas needing improvement and assisting in improvement Utilize Quality Management Systems (OMS) and other applicable databases, • Familiarity with and proper use of safety equipment and Personal Protective Equipment (PPE):, • Safety glasses, hearing protection, protective clothing, use of automated devices and equipment designed to reduce repetitive stress, etc., • Demonstrate attention to detail and complete work according to daily schedule, • Verify data against appropriate standard, • Apply product labels based on established production plan, • Fill and package product based on established production plan, • Fill and package product using standardized techniques and practices, • Stock inventory as necessary, • Support 6S programs to maintain Lean work environment, • Work occasional overtime and weekends as needed to meet production requirements, • Comply with applicable established cGMP, FDA, OSHA, EPA, and Quality System regulations, • Report all deviations from established procedural documents to the appropriate supervisor/managers., • Additional duties as defined by management and business needs, • Participate in production failure investigations, • Attend and participate in scheduled meetings, • Compose emails to groups according to good business writing standards, • Effectively present DMS Board to management and coworkers, • Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual, • Other duties as assigned or required to support the business, • Planning/organizing: Manage time and priorities, work to meet deadlines, effectively multitask with various interruptions, • Safely and correctly operate standard production and fill equipment and execute filling operations, • Perform procedures involving calculations and material measurements; collect and record data on batch records, • Correctly and safely use Laminar Flow Workstations, • Safely and correctly use automated equipment such as repeater pipette, liquid pump dispenser, auto-cappers and future production automation, • Execute Aseptic Technique, • Conduct support functions such as stocking and distributing supplies, • Fill various containers with products of various materials and sizes, • Use basic scientific laboratory equipment such as pipettes, scales, pH meters, fume hoods, and filters, • Use automated equipment such as auto-labelers and future production automated equipment, • Conduct support functions such as stocking and distributing supplies, • Apply labels to product, assemble kits, and package products, • Ensure quality is maintained by verifying information is correct and work is performed per established procedural documents, • Report any inconsistencies or non-conformances discovered during procedures, • Ensure verification and final product quality Systems/ Planning, • Utilize multiple Excel (advanced) spreadsheets and SAP functions to plan daily/weekly goals for Direct and Ventana product line without supervision, • Ensure all items on Bills of Material for specific jobs are available for use by utilizing ERP systems, • Collaborate with outside departments such as Quality, Warehouse, and Manufacturing to ensure priority orders are pushed through on time, • Exhibit professional behavior, write professional e-mails, and have good soft skills., • Work independently to meet daily goals and maintain effective communication with Leads/Supervisors, • Train other Associates in Directs and Ventana lines, • Attend and actively participate in meetings/OMS Boards, • Write and resolve deviations Perform Red-Lines on various training documents, • Perform label printing for all products when needed (Directs, Ventana, Leica, Histos, etc.), • Create and maintain Excel spreadsheets using formulas and conditional formatting., • Customer service: Respond promptly to internal customer needs from other departments, • Professionalism: Approach others in a tactful manner, react well under pressure, treat others with respect and consideration, present a professional image in all business matters, • Productivity: Meet productivity standards, strives to increase productivity without sacrificing quality and safety, • Quality: Look for ways to improve and promote quality, demonstrate accuracy and thoroughness Continuous improvement: Regularly submit suggestions for improvement (SFIs), • Ethics: Treat people with respect, keep commitments, work with integrity and ethics, uphold organizational values, • Diversity: Promote a harassment-free environment, show respect and sensitivity for cultural differences, • Teamwork: Exhibit objectivity and openness to others' views, give and welcome feedback, supports others' efforts to succeed, • Safety: Observe safety procedures, report potentially unsafe conditions, use equipment and materials properly and according to usage guidelines, • Problem solving: Identify and resolve problems in a timely manner, develop alternative solutions, • Conduct ERP transactions correctly and accurately, • Ensure paperwork matches ERP system before conducting transactions, • Return Finished Goods and Lower-Level materials into correct storage temperature by following appropriate procedures, • Review Bills of Material and accompanying paperwork for accuracy and completeness, • Stop workflow if any inconsistencies or non-conformances are found., • Bachelors degree with no experience OR, • High school diploma or GED required with a minimum of 1 year of Production or Manufacturing experience required with a minimum of 1 year of experience with general laboratory equipment strongly preferred, • Experience with SAP, SAP NEXT, or other ERP systems required, • Knowledge of and experience in a GMP facility, FDA QSRs, ISO 13485, or other related industry standards strongly preferred, • Good computer skills, including MS Office and Excel, • Good organizational skills and attention to detail, • Good verbal and written skills including the ability to create clear, concise written reports and accurately complete batch records, • Knowledge of ERP, SAP systems, • Basic math skills and knowledge of the metric system, • Demonstrated ability to learn, understand, and carry out safe laboratory practices, • Demonstrated knowledge and proficiency with personal computer hardware and software in a business environment; Microsoft 365 products preferred, • Demonstrated knowledge of Quality Management Systems (QMS) and other applicable databases #sczr2