Production Lab Tech

Job 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.
• Daily tasks may include planning, troubleshooting SAP, helping with Dev/CAPA investigations, routine laboratory maintenance, or housekeeping.

 
Job Description:
The Manufacturing team supports production of antibody products for use in in vitro diagnostic (IVD) immunohistochemistry (IHC). All Production Lab Tech II are expected to effectively perform the job functions defined in the Essential Functions and possess the skills and abilities in the Knowledge, Skills, & Abilities sections below. Level II Production Lab Tech are expected to be highly proficient in at least two of the work areas outlined in the Work Areas and Specific Tasks listed below and are expected to develop additional skills beyond the basic skills and abilities through cross-training in some or all tasks in at least one other work area. Level II Production Lab Tech performing Label and Documentation duties will perform all tasks in that area and will be proficient with Quality Systems or another Production - specific skill.
 
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
• Judgment: Make timely decisions, exhibit sound and accurate judgment

 
Work Areas and Specific Tasks:
Fill -

• 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
• Properly handle and dispose of biologically hazardous materials and chemically hazardous materials

 
Pack/Assembly -

• 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.
• Perform individual investigative work using both SAP and PSE ERP functions

 
General Responsibility:

• 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
• Assist other Techs with more advanced SAP issues (COR6N, CORS)

 
Completions :

• 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.
• SAP transactions: C060, Qe51N, COHVPI, MMBE, QA33, COR6N, COR3

 
Education and Experience:

• 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
• Previous experience in FDA regulated biotechnology or pharmaceutical environment is preferred

 
Knowledge, Skills and Abilities:

• 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

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