Sr. QC Associate - Analytical - Simply Biotech - TalentZok
San Diego, CA
About the Job
Sr. QC Associate, Analytical - Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.
Immediate opening for a Sr. QC Associate, Analytical located in San Diego, CA who possesses:
- Bachelor of Science Degree in the Biological Sciences
- 5+ years of GMP biotech experience in QC with PCR and ELISA
- 2+ years of experience with HPLC and CE
- Experience within a CMO environment is a plus
FULL DESCRIPTION: The QC Senior Associate (Analytical testing) position will work as part of the QC team to provide analytical testing for samples at the company. This position requires hands-on laboratory work and close collaboration with the Manufacturing, Process Development/Technical support, and Quality Assurance.
The selected candidate will further possess:
- Technical knowledge of analytical methods for pharmaceutical and biologic products which could include HPLC, UV/Vis Spectroscopy, qPCR, Capillary Electrophoresis, etc.
- Prior hands-on experience with qPCR and/or sequencing platforms.
- The QC Senior Associate must be accountable for the work performed, productive within the company, provide open communication, and exemplify effective teamwork skills.
- The position is responsible in performing and demonstrating the highest form of quality in the pharmaceutical industry, understanding the cGMP regulations, and implementing these practices on the work being performed.
- Knowledgeable using Microsoft Office as well as developing any documentation and creating tables for laboratory inventory and data entry.
- Highly organized, detail oriented, with excellent record keeping skills.
- Strong scientific, analytical, problem solving, and communication skills as well as sound judgement, with the ability to work both independently and effectively with others.
- Experience working in a GMP facility is highly desirable.
- Experience performing analytical testing with 21 CFR compliant laboratory equipment (HPLC, CE, qPCR).
The selected candidate will be responsible for the following:
- Perform analytical testing following established protocols. (50%)
- Develop and revise SOPs under data integrity guidelines as well as perform periodic revisions to ensure procedures are up to date with current standards. (10%)
- Perform data analysis and document results. (10%)
- Train and ensure QC personnel understand various analytical assays and standard operating procedures. (6%)
- Understand cGMP requirements related to QC laboratory operations. (6%)
- Maintain equipment and work areas according to predefined standards. (6%)
- Maintain compliance with data integrity policy and requirements. (6%)
- Support quality investigations, root cause analysis, corrective actions, preventive actions, and quality system continuous improvement initiatives. (6%)
Salary Range: $100,000-110,000/yr
For immediate and confidential consideration, please email your resumes to kchaney@simplybiotech.com or call 858.427.0687
More information can be found at www.simplybiotech.com
Source : TalentZok
