GMP Lab Equipment Coordinator

Synectics Inc.; Irvine (CA); On-site; USD 68,000 - 80,000; Full time

Job summary

A leading company in the scientific staffing sector is seeking a GMP Lab Equipment Coordinator to ensure compliance and maintenance of laboratory instruments. The role involves coordinating setup activities for new assets and supporting lab systems. Candidates should have a BS in a relevant field and experience in a GMP environment. This position offers competitive healthcare benefits and a technical certification bonus.

Benefits

Healthcare Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Technical Certification Bonus

Qualifications

• At least 3 years of relevant experience in a GMP environment.
• Strong knowledge of cGMP regulations and ICH guidance.

Responsibilities

• Monitor laboratory instruments for compliance and maintenance.
• Assist with setup and qualification of new laboratory assets.
• Support lab systems and equipment management.

Skills

cGMP

FDA

EMA

LIMS

Education

BS in molecular biology

BS in biochemistry

Tools

Asset Management System

Job description

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• Monitor critical laboratory instruments and equipment to ensure compliance with qualification, maintenance and calibration schedules, initiation of service requests and escorting vendors.
• Assist with coordination of set up and qualification activities for new assets.
• Assist with OOT investigations in the Asset Management System.
• Assist with maintenance and monitoring of stability environmental chambers, including routine visual inspection, temperature monitoring trending and coordination of cleaning and maintenance.
• Assist with stability inventory and initialization activities including receiving, storage, distributing and disposal of samples for stability studies.
• Support lab systems and equipment
• Scheduling maintenance and calibration for equipment and lab instruments in a GMP environment
• Monitor humidity and trending reports, inventories for samples.
• Focus will be on equipment management
  
  

Description

• Monitor critical laboratory instruments and equipment to ensure compliance with qualification, maintenance and calibration schedules, initiation of service requests and escorting vendors.
• Assist with coordination of set up and qualification activities for new assets.
• Assist with OOT investigations in the Asset Management System.
• Assist with maintenance and monitoring of stability environmental chambers, including routine visual inspection, temperature monitoring trending and coordination of cleaning and maintenance.
• Assist with stability inventory and initialization activities including receiving, storage, distributing and disposal of samples for stability studies.
• Support lab systems and equipment
• Scheduling maintenance and calibration for equipment and lab instruments in a GMP environment
• Monitor humidity and trending reports, inventories for samples.
• Focus will be on equipment management
  
  

Qualifications

• Must have a BS in molecular biology, biochemistry, or related field with at least 3 years of relevant experience.
• Strong working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents.
• Experienced in GMP regulated drug development environment.
• LIMS is a huge plus.
• Lab instrument/equipment related experience (coordination of calibration/maintenance activities)
• Has had more involvement in management of lab equipment within a GMP environment (coordinator of services) and review and processing of documentation (i.e calibration).
  
  

California Fair Chance Act

Synectics Inc. will consider qualified applicants with a criminal history pursuant to the California Fair Chance Act. You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if Synectics Inc. is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. Find out more about the Fair Chance Act by visiting calcivilrights.ca.gov/fair-chance-act/.

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Science

• Industries

  Staffing and Recruiting

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