New
Quality Control Senior Associate
Spectraforce Technologies | |
United States, North Carolina, Holly Springs | |
Apr 02, 2026 | |
|
Job Title: Quality Control Senior Associate Location: Holly Springs, NC Duration: 12 months 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\ Top 3 Must Have Skills: * GDP/GMP * Problem solving skillset * Collaborative skills 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. Possible Extension: * Yes Red Flags: * No chemistry background * Limited GDP/GMP experience * No lab experience Interview Process: * Will interview by phone | |
Apr 02, 2026