Job Description
Job Description
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 productPerform standard and new operating proceduresCollect and record data on documents and batch records where requiredUtilize computer hardware and software for data entry and record keeping where requiredEnsure compliance with all Quality and Regulatory specificationsSupport process improvement through identification and reporting of areas needing improvement and assisting in improvement Utilize Quality Management Systems (OMS) and other applicable databasesFamiliarity 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 scheduleVerify data against appropriate standardApply product labels based on established production planFill and package product based on established production planFill and package product using standardized techniques and practicesStock inventory as necessarySupport 6S programs to maintain Lean work environmentWork occasional overtime and weekends as needed to meet production requirementsComply with applicable established cGMP, FDA, OSHA, EPA, and Quality System regulationsReport all deviations from established procedural documents to the appropriate supervisor / managers.Additional duties as defined by management and business needsParticipate in production failure investigationsAttend and participate in scheduled meetingsCompose emails to groups according to good business writing standardsEffectively present DMS Board to management and coworkersFollow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality ManualOther duties as assigned or required to support the businessPlanning / organizing : Manage time and priorities, work to meet deadlines, effectively multitask with various interruptionsJudgment : Make timely decisions, exhibit sound and accurate judgmentWork Areas and Specific Tasks :
Fill -
Safely and correctly operate standard production and fill equipment and execute filling operationsPerform procedures involving calculations and material measurements; collect and record data on batch recordsCorrectly and safely use Laminar Flow WorkstationsSafely and correctly use automated equipment such as repeater pipette, liquid pump dispenser, auto-cappers and future production automationExecute Aseptic TechniqueConduct support functions such as stocking and distributing suppliesFill various containers with products of various materials and sizesUse basic scientific laboratory equipment such as pipettes, scales, pH meters, fume hoods, and filtersProperly handle and dispose of biologically hazardous materials and chemically hazardous materialsPack / Assembly -
Use automated equipment such as auto-labelers and future production automated equipmentConduct support functions such as stocking and distributing suppliesApply labels to product, assemble kits, and package productsEnsure quality is maintained by verifying information is correct and work is performed per established procedural documentsReport any inconsistencies or non-conformances discovered during proceduresEnsure verification and final product quality Systems / PlanningUtilize multiple Excel (advanced) spreadsheets and SAP functions to plan daily / weekly goals for Direct and Ventana product line without supervisionEnsure all items on Bills of Material for specific jobs are available for use by utilizing ERP systemsCollaborate with outside departments such as Quality, Warehouse, and Manufacturing to ensure priority orders are pushed through on timeExhibit professional behavior, write professional e-mails, and have good soft skills.Work independently to meet daily goals and maintain effective communication with Leads / SupervisorsTrain other Associates in Directs and Ventana linesAttend and actively participate in meetings / OMS BoardsWrite and resolve deviations Perform Red-Lines on various training documentsPerform 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 functionsGeneral Responsibility :
Customer service : Respond promptly to internal customer needs from other departmentsProfessionalism : Approach others in a tactful manner, react well under pressure, treat others with respect and consideration, present a professional image in all business mattersProductivity : Meet productivity standards, strives to increase productivity without sacrificing quality and safetyQuality : 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 valuesDiversity : Promote a harassment-free environment, show respect and sensitivity for cultural differencesTeamwork : Exhibit objectivity and openness to others' views, give and welcome feedback, supports others' efforts to succeedSafety : Observe safety procedures, report potentially unsafe conditions, use equipment and materials properly and according to usage guidelinesProblem solving : Identify and resolve problems in a timely manner, develop alternative solutionsAssist other Techs with more advanced SAP issues (COR6N, CORS)Completions :
Conduct ERP transactions correctly and accuratelyEnsure paperwork matches ERP system before conducting transactionsReturn Finished Goods and Lower-Level materials into correct storage temperature by following appropriate proceduresReview Bills of Material and accompanying paperwork for accuracy and completenessStop workflow if any inconsistencies or non-conformances are found.SAP transactions : C060, Qe51N, COHVPI, MMBE, QA33, COR6N, COR3Education and Experience :
Bachelors degree with no experience ORHigh 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 preferredExperience with SAP, SAP NEXT, or other ERP systems requiredKnowledge of and experience in a GMP facility, FDA QSRs, ISO 13485, or other related industry standards strongly preferredPrevious experience in FDA regulated biotechnology or pharmaceutical environment is preferredKnowledge, Skills and Abilities :
Good computer skills, including MS Office and ExcelGood organizational skills and attention to detailGood verbal and written skills including the ability to create clear, concise written reports and accurately complete batch recordsKnowledge of ERP, SAP systemsBasic math skills and knowledge of the metric systemDemonstrated ability to learn, understand, and carry out safe laboratory practicesDemonstrated knowledge and proficiency with personal computer hardware and software in a business environment; Microsoft 365 products preferredDemonstrated knowledge of Quality Management Systems (QMS) and other applicable databases#sczr2