QC Analytical Specialist II
Gilead Sciences
Summary
NOTE: Overnight Shift. Shift schedule: Saturday 11:30 PM through Wednesday 10:00 AM.
Job description
Responsibilities
- Perform testing of raw materials, intermediates, and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.
- Work with internal and external resources to maintain lab in an optimal state.
- Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
- Supply information to support generation of CoAs for product release.
- Maintains laboratory instruments for calibration and routine maintenance.
- Author or revise SOPs, qualification/validation protocols and reports.
- Assist with lab investigations regarding out of specifications (OOS) results.
- Participate in determination of root cause for deviations related to analytical procedures.
- Provide updates at daily and weekly meetings.
- Monitor the GMP systems currently in place to ensure compliance with documented policies.
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
- Gather metric information for use in continuous improvement of areas of responsibility.
- Perform other duties as required.
Basic Qualifications
- MS Degree OR Bachelor's Degree 3+ years' experience in biotechnology or related field and Quality Control experience OR AA Degree and 5+ years' experience in biotechnology or related field and Quality Control experience OR High School Degree and 7+ years' experience in biotechnology or related field and Quality Control experience
Preferred Qualifications
- Thorough knowledge of GMP, SOPs and quality control processes.
- Identifying, writing, evaluating, and closing OOS's and investigations.
- Proficient in MS Word, Excel, Power Point and other applications.
- Strong written and verbal communication skills.
- Ability to communicate and work independently with scientific/technical personnel.
- Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
- Preferred: Experience in the biotech and/or pharmaceutical industry.
Requirements
- MS Degree OR Bachelor's Degree with 3+ years' experience in biotechnology or related field and Quality Control experience OR AA Degree with 5+ years' experience in biotechnology or related field and Quality Control experience OR High School Degree with 7+ years' experience in biotechnology or related field and Quality Control experience
- Thorough knowledge of GMP, SOPs and quality control processes
- Identifying, writing, evaluating, and closing OOS's and investigations
- Proficient in MS Word, Excel, Power Point and other applications
- Strong written and verbal communication skills
- Ability to communicate and work independently with scientific/technical personnel
- Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- Experience in the biotech and/or pharmaceutical industry
Benefits
- Annual Bonus
- Stock-Based Long-Term Incentives
- Paid Time Off
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
Company overview
Gilead Sciences, Inc. is a leading American biopharmaceutical company headquartered in Foster City, California, that specializes in researching, developing, and commercializing innovative medicines for life-threatening diseases. Founded in 1987, Gilead has grown into a global healthcare leader with approximately 17,600 employees worldwide. The company's primary therapeutic focus areas include HIV/AIDS, viral hepatitis (hepatitis B and C), oncology, inflammation, and respiratory diseases. Gilead is renowned for its groundbreaking antiviral therapies, including Sovaldi and Harvoni for hepatitis C, and its comprehensive portfolio of HIV treatments such as Truvada, Atripla, and Biktarvy. The company also developed Veklury (remdesivir) for COVID-19 treatment. Gilead operates as a publicly traded company on the NASDAQ (GILD) and is a component of both the Nasdaq-100 and S&P 100 indices. Through strategic acquisitions like Kite Pharma and Immunomedics, Gilead has expanded into cell therapy and oncology, demonstrating its commitment to advancing medical science and improving patient outcomes globally.