Indiana Stem Jobs

Mobile Indiana Career Connect Logo

Job Information

Belcan QC Instrument and Systems Specialist in Indianapolis, Indiana

QC Instrument and Systems Specialist

Job Number: 307049

Category: Manufacturing

Description: A QC Instrument and Systems Specialist job in Indianapolis, IN is currently available through Belcan. 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 employee"s 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.

  • Excellent written communication skills including technical and business writing.

  • Proficiency in Microsoft Word and Excel including formatting complex scientific data for readability.

Location: Indianapolis , IN

Minimum Experience (yrs): 2-5

Required Education: Bachelor (BA, BS...)

Benefits:

Return to search results Email this job to a friend

If you have previously registered with us, pleaseLog into apply for this position.

*Logged in members may also add jobs to their job cart

DirectEmployers