Kelly Scientific is hiring for a QC Specialist II for a very successful biotech company in San Diego, CA 92121. QC Specialist II:
The purpose of this position is to perform technical activities that support data and method performance trending, method validation, and method transfer. This position will require strong technical writing skills and will be the technical liaison with Research and Analytical Development departments. This position will work closely with other QC Specialists to ensure that current and transferred methods are performing accurately and precisely. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
BS degree in a Biology, Chemistry or equivalent QC related field and 5-8 years’ experience in a GMP or similarly regulated environment such as a pharmaceutical drug manufacturing, biologics or biotechnology company.
- Design studies in accordance with the corresponding regulatory and ICH guidelines , and generate test methods and validation and transfer protocols and reports
- Execute and/or oversee method validation and method transfer studies; conduct statistical analysis, as applicable. Act as liaison with the Analytical Development department and review method qualification reports
- Train QC staff on new test methods and assist with method troubleshooting
- Assess method performance via routine trending; issue method trending reports
- Assist with statistical analysis and trending of QC product release, method control / standard, and stability data.
- Perform release testing, as assigned. EDUCATION and/or EXPERIENCE
Must also possess the following qualifications:
About Kelly Services ®
- In-depth knowledge of cGMP, GLP and FDA regulations and compendial requirements for drugs, biologic and biotechnological products
- Proven record with overseeing/executing successful method validation studies
- Proficient with statistical analysis for complex biological assays
- Proficiency with the computer software necessary to perform data handling tasks as well as accessing e-mail and filing out timesheet reports. (Microsoft Excel, Word, Outlook and Access)
- Good written and verbal communication skills.
- Familiarity with handling OOS, retest and assay validation requirements.
- Experience coordinating team and / or individual projects.
- Strong background in testing techniques, such as ELISA, cell biological, immunological, colorimetric and spectrophotometric techniques.
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class
staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually.
Revenue in 2012 was $5.5 billion.
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