Job Description
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
Job Tags
Work experience placement, Shift work, Weekend work