Job Description
Fully Onsite - Standard hours - Up to 5 days per month may require shift flexibility.
Responsibilities Under minimal supervision, the successful candidate will support the QC organization by:
•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
Basic Qualifications High school/GED + 2 years work experience OR Associate's and 6 months work experience OR Bachelor's
Preferred Qualifications:
• 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.
Job Tags
Work experience placement, Shift work, Weekend work