Quality Assurance Specialist
18 hours ago
LanceSoft is seeking a highly skilled Quality Control Chemist to join our team. As a Quality Control Chemist, you will be responsible for ensuring the quality of our products by performing testing and analysis of raw materials, intermediates, and final products.
Responsibilities- Perform testing and analysis of raw materials, intermediates, and final products using various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays.
- Work with internal and external resources to maintain the laboratory 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.
- Maintain 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.
- Bachelor's Degree OR
- Degree and 2+ years' experience in biotechnology or related field and Quality Control experience OR
- High School Degree and 3+ years' experience in biotechnology or related field and Quality Control experience
- Strong 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.
LanceSoft is a dynamic and innovative company that values its employees and provides a collaborative and supportive work environment. We offer competitive compensation and benefits packages, as well as opportunities for professional growth and development.
We are an equal opportunities employer and welcome applications from diverse candidates.
Please note that this job description is not an exhaustive list of responsibilities and may be subject to change.
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