QC Lab Analyst II

Role Summary

QC Lab Analyst II

Responsibilities

• Perform basic analysis for Validation of new and existing products on manufacturing lines in a safe, compliant, and efficient manner. Conduct wet chemistry and analytical testing to evaluate the quality of multiple sample sites across the manufacturing process to demonstrate that the process meets high standards of quality for patient use.
• Report testing results through computerized systems or standard laboratory paper-based documentation. Perform other related duties essential to these operations or special assignments as required.
• Consistently adhere to company, site, and laboratory safety rules and raise safety issues with supervision as identified.
• Follow procedures at all times, adopting cGMP, cGDP practices; follow supervisor directions; function independently but ask questions as necessary.
• Accept dynamic work sequences; be self-motivated and work with minimal direction.
• Demonstrate proficiency in computerized systems (experience with LIMS, Empower is a plus) and troubleshoot analytical methods.
• Participate in daily and weekly planning discussions to improve right-first-time and schedule adherence; identify opportunities to improve testing efficiencies.
• Communicate work sequence status to supervisor in a timely manner; participate in discussions to identify opportunities for correction and improvement when planned work is not achieved.
• Demonstrate engagement in helping to achieve QC laboratory, team, and individual goals; provide improvement suggestions during roadblocks and actively participate in improvement activities.
• Be a positive influence on the CQ laboratory and support teammates across shifts; maintain on-time training.
• Maintain proficiency in basic non-instrumental wet chemistry techniques, manual titrations, pH, conductivity, auto titrations, UV-Vis, polarimeter, and more advanced techniques such as HPLC and UPLC.

Qualifications

• Must-Have:
  • High School Diploma or GED
  • 4+ years' experience
  • Certification in assigned area, if applicable
  • Hands-on analytical testing experience in a Good Manufacturing Practices (cGMP) environment
  • Technical skills in laboratory equipment, testing, and technique
  • Basic math and computer skills, data entry, with high attention to detail
  • Strong organizational skills and ability to multi-task across projects
  • Self-motivated and able to work with minimal direction
  • Ability to read and follow written procedures
• Nice-to-Have:
  • Bachelor‚Äôs degree in chemistry
  • Proficiency in computerized systems such as Laboratory Information Management System

Skills

• Analytical testing
• Wet chemistry techniques
• LIMS and Empower familiarity (plus)
• HPLC/UPLC expertise (plus)
• cGMP/cGDP compliance
• Data analysis and documentation
• Problem solving and troubleshooting

Education

• High School Diploma or GED (Required); Bachelor‚Äôs degree in chemistry (Preferred)

Additional Requirements

• Stand up/walk for portions of shift; wear protective clothing as required
• Work schedule may include nonstandard hours; on-premise location; second shift 15:00 to 23:30