Main Responsibilities and Required Skills for a Manufacturing Associate
A Manufacturing Associate is a professional who plays a crucial role in the manufacturing industry. They are responsible for assisting with the production of goods, ensuring efficiency, and maintaining quality standards throughout the manufacturing process. In this blog post, we will describe the primary responsibilities and the most in-demand hard and soft skills for Manufacturing Associates.
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Main Responsibilities of a Manufacturing Associate
The following list describes the typical responsibilities of a Manufacturing Associate:
Adapt
Adapt, learn, re-invent and change for future development and growth.
Adhere to
Adhere to gowning procedures and maintain a clean general operating area.
Adhere to GSK policies, procedures and support site goals.
Adhere to the production schedule and provides overtime and weekend support when needed.
Apply
Apply a complete understanding of theories and principles for one's technical discipline.
Apply acquired job and company knowledge of policies and procedures to complete semi-routine tasks.
Apply company policies and procedures to complete assignments.
Apply technical skills to complete assigned work within own group / project team.
Assemble
Assemble and package kits and transfer with proper documentation.
Assemble packing boxes and package finished products into packing boxes.
Assist in
Assist die change (bolt / unbolt).
Assist in compliance and technical development projects.
Assist in setting up workstations.
Assist in the assembly and disassembly of process equipment.
Assist in the implementation of production procedures to optimize manufacturing processes.
Assist QA and manufacturing management in Lot Disposition activities.
Carry
Carry materials, tools, products, and samples throughout the cleanroom.
Carry out
Carry out work in a safe manner, notifying management of safety issues and risks.
Clean
Clean room, aseptic technique, and / or general lab equipment experience.
Complete
Complete all assigned and required training satisfactorily and on time.
Complete assigned projects.
Complete Batch Production Records under cGMP, and documents in detail.
Complete detailed documentation of all required process and manufacturing steps.
Complete tasks within standard times with minimal to no supervision.
Component
Component inspection per Solta's specifications.
Conduct
Conduct changeover and activation procedures for cleanroom suites and equipment.
Confirm
Confirm visual information in the environment such as.
Control
Control and track raw material inventory.
Coverage
Coverage for unscheduled absences are the primary responsibility of the job classification.
Create
Create, review and revise production documents.
Create what customers need next.
Develop
Develop and maintain personal development plan.
Develop and provide training on complex manufacturing processes.
Direct
Direct daily work activities and training of other staff.
Document
Document, analyze, and review data.
Document and record cGMP data.
Document equipment control data, complete logs, and verify data.
Ensure
Ensure all activities are executed following quality and regulatory standards.
Ensure all products are packaged per packaging specifications.
Ensure all relevant documentation is available as required for the process.
Ensure and maintain cleanliness of work station.
Ensure a safe work environment.
Ensure a safe working environment for all staff.
Ensure a strong culture in safety and GMP compliance.
Ensure equipment and instruments are current with calibration and preventive maintenance.
Ensure product is consistent with established specifications.
Ensure Standard Operating Procedures (SOP) are followed and reflect the current process.
Ensure temperature, time and mixing requirements are in compliance for each production.
Enter
Enter equipment control data, complete logs and form verifying data.
Escalate
Escalate processing and equipment issues, as needed.
Establish
Establish, develop and own operations documents.
Execute
Execute bioprocess operations successfully primarily in Cell Culture / Upstream manufacturing.
Execute validation protocols for reagent manufacturing processes.
Follow
Follow all mandatory actions outlines in Job Hazard Analyses.
Follow all safety related policies and procedures.
Follow and comply with company established procedures and policies.
Follow manufacturing work instructions and training.
Follow verbal and written directions.
Follow Written Work Instructions.
Foster
Foster Collaboration and Teamwork.
Foster teamwork, common goals, selflessness, communication and mutual support.
Generate
Generate and revise internal and external documents (SOPs, BRs).
Handle
Handle and transfer semiconductor wafers within the cleanroom.
Handle material used on pallets.
Identify
Identify, creates and revises GMP documentation as required including MBRs.
Identify, escalates and documents events and subtle variances that deviate from normal operation.
Identify key process bottlenecks and implement process improvements to minimize bottleneck.
Identify and help mitigate EHS and safety risks.
Identify and implement process improvements.
Input
Input production data into SAP using the ACSIS program.
Interact with
Interact with clients during initial and subsequent manufacturing campaigns.
Interact with other departments.
Interact with QA when compliance issues arise.
Interact with the Downstream process development group during the technical transfer of new programs.
Lift
Lift, bend, walk, stoop, and stand for a 12 hour shift.
Lift completed assemblies from weld fixtures.
Lift up to 30 - 35 pounds.
Maintain
Maintain accurate inventory, inventory controls and procurement to support production activities.
Maintain accurate material control within the work area.
Maintain accurate records and documentation related to product / process.
Maintain a clean and well stocked workstation.
Maintain all associated documentation for operations being performed.
Maintain appropriate inventory levels of raw materials and supply items used in production.
Maintain batch record documentation and logs as required by corporation and regulatory agencies.
Maintain cell culture flasks using good aseptic techniques.
Maintain effectiveness of Quality system.
Maintain facility and room inspection readiness.
Maintain orderly lab space.
Maintain the Pilot Plant laboratory under cGMP conditions.
Manage
Manage Components to Support Production.
Manage inventory levels for production.
Manage inventory, plan, and execute scheduled production work-orders.
Manage multiple projects independently.
Monitor
Monitor assigned machinery and clear jams as they occur.
Monitor critical process parameters.
Operate
Operate and troubleshoot high-speed automated Inspection and Packaging equipment.
Operate conventional stamping press equipment.
Operate equipment as needed and dictated by the process.
Operate sealing machines (pouch and tray).
Operate production equipment according to SOP's in their assigned areas.
Participate in
Participate as needed in investigations.
Participate in and support continuous improvement, and LEAN initiatives.
Participate in area continuous improvement activities.
Participate in daily meetings.
Participate in deviation writing, root cause investigations, and CAPAs when necessary.
Participate in facility expansion and equipment validation activities.
Participate in investigations both EHS and Quality related.
Participate in projects such as Internal Assessment, Material Management, Yield Improvement, etc..
Perform
Perform 1st piece run inspection process.
Perform
Perform basic laboratory tasks, such as monitor pH, conductivity, test product samples, etc.
Perform batch record review, procedure revisions, and work order generation.
Perform Cleaning and Sanitization of ISO5, ISO7, ISO8 classified rooms and associated equipment. (.
Perform Clean-In-Place, Clean-Out-of-Place, and equipment sterilization.
Perform document revisions to Standard Operating Procedures.
Perform equipment and area cleaning processes as necessary.
Perform GMP manufacturing operations safely, reliably and in compliance with stated processes.
Perform good documentation practices that meet cGMP guidelines.
Perform in-process inspection of components and assemblies to verify quality conformance.
Perform routine assignments with supervision.
Perform routine Quality and Safety inspection walk-throughs of the production areas.
Perform Sanitation of WFI Cold Distribution Loop.
Perform the tasks of the production operation specific to aseptic manufacturing.
Perform variety of hands-on manufacturing tasks to produce molecular kits.
Prepare
Prepare equipment and mix compounds.
Prepare for production by reviewing production schedule.
Prepare solutions and culture media as appropriate.
Process
Process work orders and follow protocols to complete production of kits for shipment.
Promote
Promote and implement use of continuous improvement tools to eliminate non-value activities.
Provide
Provide feedback and / or suggested changes to operational procedures.
Provide feedback to manager on recommendations for procedural and process improvements.
Provide team with sufficient information and support to accomplish team goals.
Receive
Receive detailed instructions on all work.
Recognize
Recognize issues and escalate to senior staff.
Record
Record / enter data on job sheets.
Report
Report any safety issues immediately.
Represent
Represent GSK with the highest level of integrity and professionalism.
Represent Manufacturing in cross functional initiatives and meetings.
Review
Review operational protocol(s) and production records as needed.
Revise
Revise or create documents as instructed.
Routine
Routine assembly / disassembly and cleaning of manufacturing equipment.
Set-up
Set-up equipment operation feed, speed and temperature.
Set-up and breakdown of machines and fixtures for processing.
Set-up and operate press fit and detab machines.
Sort
Sort and maintain stock of aseptic supplies and gowning materials.
Stage
Stage raw materials / components for use within cGMP Biomanufacturing.
Sterilize
Sterilize equipment, either in the tabletop or large autoclave.
Support
Support all CQV activities on site.
Support compliance with Solta quality system and good manufacturing practices.
Support / manage sustaining activities and drive cost reduction.
Support New product Builds.
Support operational excellence initiatives, and the implementation of new technologies and systems.
Support trending of defined department metrics.
Train
Train and mentor less experienced staff.
Train Manufacturing Technicians on theories and concepts of the bioprocess operations.
Train other associates as required.
Transact
Transact inventory in an ERP system.
Troubleshoot
Troubleshoot and resolve issues.
Troubleshoot process deviations resulting from automation communication issues.
Troubleshoot complex equipment and implement solutions.
Understand
Understand and adhere to cGMP requirements.
Update
Update job knowledge by participating in training opportunities.
Use
Use laboratory tools and skills to synthesize oligonucleotides.
Utilize
Utilize manufacturing knowledge to improve process operations and affect positive change.
Verify
Verify the raw materials are in conformance to product recipe.
Weigh out
Weigh out chemicals and prepare medium and / or buffer solutions following detailed instructions.
Work
Work and communicate closely with other departments both inside and outside of the Value Stream.
Work as member of assembly team building units to completion.
Work as part of the Manufacturing team to meet Production goals.
Work in areas where handling human blood products (Biosafety Level 2) may be required.
Work in Clean Room Environment.
Work is based on specific guidelines for each machine and part.
Work may involve repetitive arm / wrist motions.
Work outside in the elements.
Work with Coordinator and Engineering to improve processing.
Work with supervisor and QA to mitigate identified issues.
Work with TechOps teams to execute technology transfers and capacity building projects.
Most In-demand Hard Skills
The following list describes the most required technical skills of a Manufacturing Associate:
Proficiency in operating manufacturing equipment and machinery.
Knowledge of quality control principles and practices.
Understanding of manufacturing processes and workflow.
Technical expertise in using tools and instruments for measurement and testing.
Ability to read and interpret technical drawings and blueprints.
Familiarity with computer-aided design (CAD) software for product visualization.
Experience with statistical analysis and data interpretation.
Strong mathematical and analytical skills for problem-solving.
Knowledge of safety regulations and procedures in a manufacturing environment.
Proficiency in using productivity software such as Microsoft Excel or ERP systems.
Basic understanding of electrical and mechanical systems.
Experience with lean manufacturing principles and methodologies.
Ability to work with hand tools and perform basic equipment maintenance.
Knowledge of inventory management and control systems.
Understanding of automation and robotics in manufacturing processes.
Proficiency in using specialized software or programming languages for process control.
Knowledge of manufacturing regulations and compliance standards.
Familiarity with process improvement techniques, such as Six Sigma or Kaizen.
Ability to troubleshoot and diagnose equipment malfunctions.
Proficiency in operating material handling equipment, such as forklifts or pallet jacks.
Most In-demand Soft Skills
The following list describes the most required soft skills of a Manufacturing Associate:
Strong communication skills for effective collaboration and information sharing.
Attention to detail and accuracy in performing tasks.
Ability to work effectively in a team-oriented environment.
Problem-solving skills to identify and resolve issues.
Flexibility and adaptability to changing priorities and tasks.
Time management and organizational skills to meet deadlines.
Initiative and self-motivation to take ownership of tasks.
Positive attitude and willingness to learn and improve.
Stress management and resilience to work in fast-paced manufacturing settings.
Interpersonal skills for building relationships and resolving conflicts.
Conclusion
A Manufacturing Associate has a diverse range of responsibilities, from operating machinery to ensuring quality control. Possessing a combination of technical expertise, problem-solving abilities, and strong communication skills can make a Manufacturing Associate a valuable asset in the manufacturing industry.
