Sign up free to see how well your resume matches this role.
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
To perform this job successfully and safely, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.
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 escalate 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 Abilities
Ability to read and interpret instructions, procedures, manuals, and other documents
Strong verbal and written communication skills
Knowledge of cleaning methods and equipment and willingness to share with team
Knowledge of the upkeep and care of the cleaning equipment
Knowledge of cleaning compounds and chemicals, and their safe, efficient use
Supervisory Responsibilities
This position has no supervisory responsibilities.
Physical Demands & Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit and talk or listen. The employee must be able to lift and/or move up to 35 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Shifts and Compensation
Sunday-Thursday 7am-330pm
$20-$21 per hour
SBM offers comprehensive benefit packages. For information about SBM's benefits, please visit SBM's website at:
www.sbmmanagement.com/careers Careers – SBM
SBM Management Services, LP and its affiliates are proud to be equal opportunity workplaces. We are committed to equal employment opportunity regardless of race, sex, color, ancestry, religion, national origin, sexual orientation, citizenship, age, marital status, disability, gender identity, Veteran status, or other legally protected status.
