Specialist Ii, Qc Investigations

Specialist II, Quality Control Investigations – Competitive Salary + Great Benefits + Hybrid

Suitable for: QC Specialist, QC Specialist II, QC Sr Specialist, QC supervisor, Investigation Analyst, Investigation Associate

Are you looking for the next step in your Quality Control career in a fast-paced environment? If so come and join us to help the development of the life sciences industry, developing innovative ways to treat patients.

We are offering a permanent position as a Specialist II, QC investigations in a meaningful environment, with a competitive salary package, including other benefits.

Please contact Hugo Poitel at +1 (646) 582-3683 or by email at [email protected] for more information about this exciting opportunity

For this exciting QC Specialist II role, your main duties include, but are not to be restricted to, the following duties:

• Participate in laboratory investigations including deviations and out of specifications
• Authoring and revision of standard operating procedures, test methods, protocols, and reports in accordance with GDP
• Enumeration, bacterial endotoxin, and bioburden
• Testing of material utilizing methods such as FTIR, qPCR, Karl Fischer, Gel electrophoresis,
• Perform equipment calibrations, troubleshooting and optimization, and analysis of cell viability
• Participate in the execution of raw material testing, stability testing, environmental monitoring, critical utility monitoring, method qualifications, technical transfers, release testing, and method validations

To be successful in this role, your experience will need to include:

• Experience with FDA, ICH, and EU Regulations and Guidelines
• Strong technical laboratory skills (e.g. pipetting, weighing, and measuring pH)
• Involvement in continuous improvement initiatives and laboratory investigation
• Experience with writing, managing SOPs
• 5-7 years of experience in Quality Control in a GMP environment,
• B.S. degree in science or a life science-related field of study
• Experience in the culture of microbiological organisms, operation of microscopes, and equipment calibrations (e.g. pH meters and balances)

MEDICAL REQUIREMENTS

COVID-19 vaccine required to come on-site; Individuals seeking an exemption from this requirement for medical or religious reasons should reach for an accommodation.

Interested in finding out more?

The full job description is available post-application, please apply below. This role is being managed by Hugo Poitel at Meet, please contact me at +1 (646) 582-3683 or directly by email at [email protected] to confidentially discuss it.