QC Analyst I
7555 Gateway Boulevard Newark, CA 94560 US
Job Description
The QC Analyst I will prepare QC reagents and solutions per the appropriate SOP. Performs routine assays (pH, Appearance), routine laboratory maintenance tasks including organization and cleaning of work areas, checking for expired reagents and standards, disposal of product samples, chemicals and hazardous waste. Order of laboratory materials and supplies as needed. With assistance from QC analysts oversee the calibration, maintenance and operation of lab instrumentation. Coordinate with the document control department for the timely filing of QC records and for the issuance of QC logbooks.
Responsibilities/Essential Duties:
- Preparation of QC reagents and solutions per applicable SOP
- Maintain required inventory of laboratory materials and supplies
- Routine inventory check of product and appropriate disposal
- Perform frequency appropriate cleaning of laboratory equipment and waste disposal
- Oversee calibration and maintenance of lab instruments
- Perform routine and non-routine release, stability, and in-process sample testing (i.e. Appearance, pH, Water Content) and documentation under cGMP
- Receive samples for QC testing via coordination with other departments, i.e. manufacturing
- Assist with shipping samples to contracting labs
- Issuance of QC logbooks
Minimum Required: • BA or BS degree in a scientific discipline preferred, or comparable experience.
• Understanding or prior experience of molecular biology techniques such as Western blot, SDS-PAGE, and/or ELISA.
• Prior experience working in Quality control or Quality Assurance.
• Minimum 2-4 years' experience in pharmaceutical industry environment or equivalent combination of education and experience.
• Experience working in cGMP or GLP pharmaceutical industry environment preferred.
Minimum Required: • Ability to perform technical review of data following GxP regulations and scientific principles.
• Proven ability to manage multiple assignments/ tasks.
• Ability to communicate clearly and effectively, both verbally and in writing.
• Ability to effectively work in fast pace environment with cross functional groups involved in multiple projects and timelines.
• Ability to manage and coordinate all tasks assigned and effectively complete all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
• Must be familiar with ICH, FDA and EU guidelines.
• Demonstrates strong attention to detail and a high level of quality, consistency, and accuracy in work effort.
Education:Â Â Â
- Bachelor’s degree REQUIRED and 1-2 years of directly related QC experience.
- 1-2 years in a Quality Control laboratory environment (GMP environment)
- Hands-on experience with a wide range of analytical techniques such as Appearance, pH, SDS-PAGE and Western Blot
- Must be able to maintain data integrity, and understanding of US and international (e.g. EU, ICH, GXP) regulations.
- Ability to manage multiple tasks and meet deadlines with a high tolerance for ambiguity, solutions oriented and able to problem solve and identify root cause.
Pay Rate Range: $30-48/hr. Salary will be commensurate with experienceÂ
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About Newark, CA
Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
