GMP Laboratory Equipment Specialist - Quality Assurance
Salem, NH 
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Posted 6 days ago
Job Description

Pace Analytical Life Sciences is hiring a GMP Laboratory Equipment Specialist to manage the qualification/calibration program at the Salem, NH location. This position offers the opportunity to develop and execute custom facility and equipment qualification protocols, manage the calibration/qualification service provider program, and ensure calibration and qualification is performed per established quality system requirements. Self-directed individuals with the ability to function in complex industrial and lab environments will thrive in this position. Pace is a growing provider of life sciences services and products with offices across the US. Join our fast-paced support team today!


Responsibilities:

  • Support development of custom Installation Qualification, Operation Qualification and Performance Qualification (IQ/OQ/PQ) protocols for equipment including HVAC and cleanroom facilities, purified water systems, compressed air and gas systems, autoclaves, ovens, and other equipment
  • Support on-site testing and report completion of custom Installation Qualification, Operation Qualification and Performance Qualification (IQ/OQ/PQ) protocols for equipment listed above including use of Kaye Validator system.
  • Manage calibration/service supplier program
  • Schedule calibration/qualification events
  • Ensure calibration and qualification is performed per established quality system requirements.
  • Prepare GMP compliant test reports
  • Prepare or assist in writing, reviewing, approving and implementing standard operating procedures (SOP's)
  • Initiate proper change control, deviation, out of specification and investigation documentation when required
  • Update pertinent logs and tracking systems as they relate to the company's Quality Systems

Qualifications:

  • Relevant experience working with GMP critical utilities or in cleanroom certification, metrology, or other related testing or technical tasks is desired
  • Ability to understand technical drawings and manuals
  • Strong technical aptitude as demonstrated through work or educational experience
  • Ability to extract technical requirements from various sources and create executable protocols from the technical requirements
  • Must possess strong interpersonal skills and have the proven ability to communicate with employees/customers/clients in both oral and written form; fluent in the English language
  • Knowledge of various regulatory systems and guidelines (FDA and EU GMP's, etc.)
  • Must be detail oriented, organized and possess the ability to be flexible to meet the needs of technical employees across multiple departments
  • Computer skills, MS Office and specialized programs
  • Bachelors degree in engineering or related field.
  • Technical writing ability
  • Basic math skills including geometry and algebra
  • Ability to work in a self-directed, fast paced environment

Physical/Mental Requirements:

Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.

Working Environment:

Work is performed in lab and office settings. Work is subject to exposure to blood or bodily fluids, chemicals, fumes, gasses, noxious odors, and related items in a lab and environmental setting.


OFCCP Statement:

Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, and individuals with disabilities, sexual orientation, or gender identity

Full-time day shift working Monday through Friday. Evening and occasional weekends hours may be required based on manufacturing schedule.


#STAR


This role is working first shift Monday through Friday. From time to time this position may need to come in early, stay late, and occasional weekend work to meet the needs of clients.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
Open
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