Senior Quality Control Associate
Holly Springs, NC
Contract
Onsite
1 month ago
About the role
Target PR Range: 32-42/hr DOE
Responsibilities
Under minimal supervision, the successful candidate will support the QC organization by:
Support routine activities over the weekends and public holidays as required
Basic Qualifications
High school/GED + 2 years work experience OR Associates and 6 months work experience OR Bachelors
Preferred Qualifications
Responsibilities
Under minimal supervision, the successful candidate will support the QC organization by:
- Conduct analytical testing, in accordance with SOPs, to characterize various substances and materials.
- Perform variety of assays and routine laboratory procedures under minimal supervision and in accordance with SOPs.
- 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 Associates and 6 months work experience OR Bachelors
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.
Skills
Staffing and Recruiting