GMP Lead Lab Services Tech

Pacific West Site Services, Inc.; New Albany (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

Pacific West Site Services, Inc. seeks a GMP Lead Lab Services Tech to ensure adherence to SBM and customer SOPs, maintain a clean lab, report issues, and coordinate with QC and MSAT labs to sanitize glassware and perform steam sterilization.

You will operate washers, autoclaves, HMI and OLRT, stay trained on SOPs, train new staff, and serve as onsite point of contact for Automation, Maintenance, Instrumentation, QC & MSAT Labs, and Manufacturing.

Qualifications

• High school diploma / GED required.
• At least 2-years related experience.
• May be required to have a valid driver's license.
• Completed all safety and task training certification.

Responsibilities

• Comply with safety rules, policies, and all SOPs relevant to perform responsibilities.
• Perform work assignments in a team with other employees.
• Maintain clean work area and report any facility fit issues in accordance with site policies.
• Coordinate and act as a point of contact for QC/MSAT lab users with requests or changes to operations.
• Take direction and respond to supervision.
• Communicate with supervisor, coworkers, managers and customers in a professional manner.
• Use proper personal protective equipment for all tasks being performed.
• Present a professional appearance and conduct.
• Understand customer service, reporting systems and GMP environment.
• Perform glassware sanitization and steam sterilization while using a combination of systems and equipment (HMI, OLRT, DCS, Washers, Autoclaves, etc.).
• Keep the lab equipment such as washers and autoclaves in orderly condition while communicating with the supervisor and appropriate groups to service equipment.
• Perform weekly, monthly and quarterly tests/cleaning on autoclaves as applicable with proper tools.
• Perform repetitive tasks in a GMP environment.
• Schedule recipes and maintain GMP compliance while documenting data and operating equipment.
• Must be trained and certified in correct gowning procedures for assigned areas.
• Provide recommendations for corrective action on areas that need improvement.
• Complete all basic training modules and annual qualification training per SBM and site SOPs.
• Understanding of various chemicals and solutions and how to identify expiration information.
• Prep labware for sanitization (Removing labels, markings, excess residue).
• Prep labware for steam sterilization as necessary including adding steam indicator tape, manual wash of equipment and proper labeling.
• Assemble various tubing assemblies and bioreactors in MSAT (Non-GMP) Lab as needed while following safety guidelines and RP's.
• Track and maintain supply inventory; communicate with supervisor when equipment is needed and ensure all tools are fit for use in all areas.
• Perform quality, service, and safety inspections.
• Report incidents, hazardous conditions, and customer issues to supervisor.
• Monitor employees for proper use of personal protective equipment for all tasks performed and correct at risk behavior and report to the supervisor immediately.
• Ensure that all frequency-based cleaning and tests are scheduled and performed in a timely manner.
• Assist the supervisor in training of lab services team members and ensuring that team is compliant when performing tasks.
• Maintain and update various excel sheets used for lab services program such as equipment alarm list, supplies needed and hose tracker.
• Perform review of OLRT recipes in a timely manner and confirm that all data is correct and compliant and elevate to supervisor or QA if necessary.
• Assist in reviewing of SBM's SOPs and other various documents to ensure accurate information.
• Point of contact for demonstration of service provided and overall ability to speak to the lab services program.

Education

High school diploma / GED

2+ years related experience

Job description

Title: GMP Lead Lab Services Tech

Job Overview

The GMP Lab Services Tech, Lead role will be responsible for adhering to SBM and customer SOP's while helping to ensure a clean lab environment, report any lab or facility fit issues and coordinate with QC and MSAT labs to sanitize glassware, perform steam sterilization and assembly of lab equipment upon request. This individual will operate a combination of systems and equipment such as washers, autoclaves, HMI and OLRT to schedule recipes and perform sanitizing/sterilization. This role is expected to understand and follow SOP's and stay compliant on all training needed to perform responsibilities. This individual will keep assigned areas and equipment clean and in orderly condition and will work successfully with co-workers, customers, contractors and others. This role will be the point of contact for several groups onsite (Automation, Maintenance, Instrumentation, QC & MSAT Labs, Manufacturing). This individual will aid in training new co-workers, maintaining SOP's up to date and communicating any requests to ensure the lab services team has all necessary PPE and equipment needed.

Roles & Responsibilities

• Comply with safety rules, policies, and all SOP's relevant to perform responsibilities.
• Perform work assignments in a team with other employees
• Maintain clean work area and report any facility fit issues in accordance with site policies
• Coordinate and act as a point of contact for QC/MSAT lab users with requests or changes to operations
• Take direction and respond to supervision
• Communicate with supervisor, co-workers, managers and customers in a professional manner
• Use proper personal protective equipment for all tasks being performed
• Present a professional appearance and conduct
• Understand customer service, reporting systems and GMP environment
• Perform glassware sanitization and steam sterilization while using a combination of systems and equipment (HMI, OLRT, DCS, Washers, Autoclaves, etc.)
• Keep the lab equipment such as washers and autoclaves in orderly condition while communicating with the supervisor and appropriate groups to service equipment
• Perform weekly, monthly and quarterly tests/cleaning on autoclaves as applicable with proper tools
• Perform repetitive tasks in a GMP environment
• Schedule recipes and maintain GMP compliance while documenting data and operating equipment
• Must be trained and certified in correct gowning procedures for assigned areas
• Provide recommendations for corrective action on areas that need improvement
• Complete all basic training modules and annual qualification training per SBM and site SOP's
• Understanding of various chemicals and solutions and how to identify expiration information
• Prep labware for sanitization (Removing labels, markings, excess residue)
• Prep labware for steam sterilization as necessary including adding steam indicator tape, manual wash of equipment and proper labeling
• Assemble various tubing assemblies and bioreactors in MSAT (Non-GMP) Lab as needed while following safety guidelines and RP's
• Track and maintain supply inventory; communicate with supervisor when equipment is needed and ensure all tools are fit for use in all areas
• Perform quality, service, and safety inspections
• Report incidents, hazardous conditions, and customer issues to supervisor
• Monitor employees for proper use of personal protective equipment for all tasks performed and correct at risk behavior and report to the supervisor immediately
• Ensure that all frequency-based cleaning and tests are scheduled and performed in a timely manner
• Assist the supervisor in training of lab services team members and ensuring that team is compliant when performing tasks
• Maintain and update various excel sheets used for lab services program such as equipment alarm list, supplies needed and hose tracker
• Perform review of OLRT recipes in a timely manner and confirm that all data is correct and compliant and elevate to supervisor or QA if necessary
• Assist in reviewing of SBM's SOP's and other various documents to ensure accurate information
• Point of contact for demonstration of service provided and overall ability to speak to the lab services program

Qualification

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job safely. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

Education and/ or Experience

• High school diploma / GED required
• At least 2-years related experience

Certificates, Licenses, Registrations

• May be required to have a valid driver's license
• Completed all safety and task training certification

Knowledge, Skills, and