QC Metrology Support Specialist - Pharmaceuticals

ADN Healthcare

NOW HIRING! QC Metrology Support Specialist in Charlotte, NC

Job Type: Direct

Pharmaceutical manufacturer on the south side of Charlotte, NC. Strong growth potential and very active team/family environment.

Job Description

The Quality Control (QC) Metrology Support Specialist position supports the day-to-day operation and maintenance of the QC analytical equipment. Primary responsibilities for this position will be:
Support the setting-up and overseeing the IQOQPQ process for laboratory instrumentation.
Responsible for performing or overseeing the calibration of analytical instrumentation in the QC and Microbiology laboratory.
Responsible for the repair or overseeing the repair of analytical instrumentation in the QC and Microbiology laboratory.
Responsible to implement and maintain procedures and systems in support of RM, IP, FP and stability testing in the QC laboratory and Microbiology laboratory.

Qualifications
  • Bachelor's degree in Chemistry, or closely related scientific discipline. Degree in Chemistry is highly preferred
  • A minimum of 3 years in the field of Pharmaceutical (manufacturing facility)
  • Experience with laboratory instrumentation qualification and calibration process
  • Experience with compendia techniques (identification, wet chemistry, limit)
  • Strong understanding of cGMP's cGLP's, FDA regulations, and industry guidelines, as well as international regulatory guidelines
  • Knowledge in general laboratory equipment including but not limited to: HPLC, GC, UV-Vis and FTIR
Knowledge & Skills

  • Must be proactive, results oriented, with a strong attention to detail
  • Self-starter with good-work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team
  • Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment
  • Strong organizational, analytical, troubleshooting and problem-solving skills
  • Ability to analyze details and perform structured decision-making on a daily basis
  • Excellent verbal and written communication. Must be able to effectively communicate with multicultural individuals. Must be able to communicate at a technical level with vendors
  • Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner
  • Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc.
  • Knowledge of LIMS (Laboratory Information Management System) is a plus
  • Knowledge of cGMP, Regulatory guidelines, Compendial testing (USP), Internal auditing
  • Skills in coordination of calibration and preventative maintenance services, including but not limited to:
    setting up vendor contracts
    processing quotes
    generating purchasing orders
    handling vendor invoices
  • Technical writing skills to generate SOPs and serve as the Subject Matter Expert