Instrumentation Specialist


**POSITION AVAILABLE:** **QC Instrument and Systems Specialist**


This is a professional mid-level technical position that will be responsible for the implementation and maintenance of the QC analytical instruments and software systems, and writing, executing and managing instrument qualification protocols.


**MAJOR RESPONSIBILITIES:**


+ Maintain QC analytical instruments and software systems.

+ Schedule PM and calibration of instruments with vendors. Maintain documentation of maintenance


performed for cGMP systems.


+ Initiate and manage Change Control requests for commissioning/decommissioning equipment and/or


software, new processes, and process improvements.


+ Initiate and oversee Capital Projects related to QC equipment, serving as Project Coordinator for


internal and external agencies.


+ Write, execute and summarize instrument IQ/OQ/PQ protocols.

+ Write/revise SOPs and ICMs for the use and maintenance of laboratory equipment and related


software, and conduct training as the Subject Matter Expert.


+ Perform periodic reviews of documents associated with equipment, to ensure they are kept up-to-date


and meet compliance requirements. Coordinates with analysts for timely investigation of out of specification


and non-conformance events related to instrumentation. Reviews investigation reports


for accuracy and completeness.


+ Perform weekly power cycling of all laboratory instrumentation.

+ Other duties as assigned.

+ As a part of the employees job requirements, the employee may be required to handle wastes


including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.


**SCOPE:**


+ 50% Instrument maintenance

+ 50% Management of Equipment Change Controls


**REQUIREMENTS:**


+ BS in chemistry or related discipline with a minimum of two years experience in the pharmaceutical industry.

+ Demonstrated ability to perform analytical testing using the majority of the analytical equipment used in the analytical laboratory including HPLC, GC, TLC, UV/VIS Spectroscopy, FTIR Spectroscopy,

+ Particle Size, Electrophoresis, etc.

+ Must have solid cGMP expertise in testing/manufacturing environments.

+ Technical knowledge of bio-analytical and chemistry analytical techniques: GC (Agilent), HPLC


+ (Waters, Wyatt), Chromatography Software (Waters Empower 3, Wyatt Astra), SDS-PAGE (GE, Bio-

+ Rad), TLC (Camag), UV/Vis Spectroscopy (Agilent, Thermo), FTIR Spectroscopy (Perkin Elmer),

+ Particle Size (Malvern), Osmometer (Wescor), Titration (Mettler Toledo, Metrohm)


+ Familiarity with analytical instrument validations.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)