QC Chemist III

Summary / objective
The primary function of a QC Chemist is to perform qualitative and quantitative chemical and physical analysis in support of raw materials, in-process samples, components, and finished drug products testing.

 

Essential functions

• A CIII completes most non-routine testing independently. May perform non-routine testing, method validation, and instrument qualification with limited supervision
• A CIII has strong oral and written communication skills to meet established policies and procedures
• A CIII has a strong understanding of Analytical Chemistry and can independently perform most testing required in the QC Lab.
• A CII has high understanding of applicable cGMP, DEA regulations, and Quality Procedures for working in a QC Lab
• A CIII knows the concepts of statistical treatment of experimental data. Proposes conclusion congruent with experimental results
• A CIII identifies non-routine technical problems and recommends solutions. Has a strong skill set for OOS, OOT, and aberrant result investigations
• A CIII has advanced level of lab instruments and equipment knowledge and advanced trouble shooting skills. May participate in technical discussions with other departments.
• Specialized
  • Tech Support – Non-routine testing independently
  • Validation – Writes documents with limited supervision
  • Qualification - Limited supervision
  • Instrumentation – Advanced
  • Documentation Review – 2PV data, protocols, reports
• Accountability
  • Budget – Operate within dollar amount given
  • Self and Group Development – A CIII recognizes deficiencies in advanced and specialized areas for self
  • Documentation – Creates documents from templates
  • Ethics – Has declarative and procedural knowledge of “Data Integrity and Ethics”
• Supervision
  • A CII works with minimum supervision and mentors a coworker
  • No supervision of others

 

Work environment

This role operates in a professional office environment business casual/casual attire is required.  This role requires the use of standard office equipment such as computers, phones, photocopiers, and fax machines. 

 

Physical demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.The employee must regularly lift and/ or move up to 50 pounds. Specific vision abilities required by this position include close vision, color vision and the ability to adjust focus. While performing the duties of this job, the employee is regularly required to stand, walk, sit and talk or hear. The employee is occasionally required to climb or balance, stoop, kneel, crouch, crawl and smell.

 

POSITION TYPE/EXPECTED HOURS OF WORK
This is a full-time position. Hours of work can vary, depending on which shift the employee is assigned

 

Required education and experience

• Advanced excel skills preferred but not required
• Professional
• Reliable and dependable
• Organized and detail oriented
• Highly efficient and accurate
• Confidentiality
• Abstract problem-solving skills
• Strong communication skills

Preferred education and experience

• BA/BS Chem 3-5 yrs
• MS 2-4yrs
• Ph.D 1-2yrs
• Keep up with Advanced Technology

Work authorization/security clearance (if applicable)

• Authorized to work in the United States
• DEA background clearance