Analytical Chemist (Quality Control Analytical Testing

Job Title:
Quality Control Senior Associate

Location:
Holly Springs NC – 100% onsite

Duration: 12 Months with possible extension

Terms:
Contract W2

Description:

Fully Onsite
- Standard hours
- Up to 5 days per month may require shift flexibility.

• Conduct analytical testing, in accordance with SOP’s, to characterize various substances and materials.
• Perform variety of assays and routine laboratory procedures under minimal supervision and in accordance with SOP’s.
• Maintains equipment to uphold laboratory standards.
• Manages samples efficiently ensuring proper handling and documentation.
• Evaluates data analysis and applies GMP procedures.
• Assisting with procurement activities for consumables and critical reagents for lab start up.
• Experience with for HPLC, UPLC, TOC, UV and other related Chemistry bench top Equipment (OSMO, Turbidimeter, pH and Conductivity).
• Participating in the QC Chemistry testing activities including validation and method transfers.
• Assisting with creating and collaborating on Data Integrity Assessments for computerized lab systems.
• Author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports, method assessments, and technical assessments.
• Assisting with procurement activities for consumables and critical reagents for lab start up.
• Ensure successful training and method transfer activities for HPLC, UPLC, TOC and other related Chemistry bench top Equipment.
• Own and manage Deviation, CAPA and Change Control records to support Quality Control.
• Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
• Support routine activities over the weekends and public holidays as required

High school/GED + 2 years work experience OR Associate’s and 6 months work experience OR Bachelor’s

• Degree in a related scientific field such as Chemistry, Biochemistry, Physics or Chemical Engineering.
• 4+ years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.
• Strong knowledge of laboratory techniques.
• Proficient in the use of LIMS & LMES/CIMS.
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.
• Strong written and verbal communication skills including technical writing and presentation.
• Experience with equipment and method validation, verification, and transfer including the change control process.
• Interact effectively with variety of communication and working styles and ability to work well in teams.