Quality Control Analyst

Quality Control Analyst

Title: Quality Control Analyst Level II or Level III

Location: Gainesville, FL

Industry: Pharmaceutical

Schedule: Monday - Friday 8am - 5pm

Salary: up to $35/hr. based on experience

Employment: Contract to Hire

The Quality Control Analyst will primarily be responsible for supporting and leading early/late phase and commercial quality control activities. This highly motivated member of the Quality Unit will support the organization through the execution of activities such as raw material testing, release testing, stability testing, and environmental monitoring. As part of the Quality operations, you will be responsible for initiating and assisting in investigations and troubleshooting while adhering to cGMP and GDP practices.

Essential Duties and Responsibilities

QC Analyst II:

Actively participate in fostering a positive, collaborative work culture.

Author and revise standard operating procedures, test methods, protocols, and reports.

Perform execution of raw material testing, stability testing, environmental monitoring, critical utility monitoring, method qualifications, technical transfers, release testing, and method validations.

Testing of material utilizing methods such as pH, Osmolality, Appearance, cell culture, dPCR, ELISA, and other assays used for release and characterization of products.

Ensure QC deliverables are met in a timely manner.

Perform data analysis and review.

Participate in laboratory investigations including deviations and out of specifications.

Perform equipment calibrations.

Execute method and equipment troubleshooting and optimization, as needed.

Maintain documentation in accordance with GDP. QC Analyst III

Actively participate in fostering a positive, collaborative work culture.

Author and revise standard operating procedures, test methods, protocols, and reports.

Lead in execution of raw material testing, stability testing, environmental monitoring, critical utility monitoring, method qualifications, technical transfers, release testing, and method validations.

Assist in the transfer of assays from the Analytical Development Lab to the QC Lab.

Demonstrate proficiency in flow cytometric, automated cell counting, dPCR, qPCR, ELISA-based, multiplex cytokine detection, pH, endotoxin, and cell-based assays.

Ensure QC deliverables are met in a timely manner.

Perform data analysis and review.

Initiate and participate in laboratory investigations including deviations and out of specifications.

Perform equipment calibrations.

Execute method and equipment troubleshooting and optimization, as needed.

Maintain documentation in accordance with GDP.

Train and cross train QC personnel on standard operating lab procedures and test methods. Qualifications

Required:

B.S. degree in science or a life science-related field of study

Minimum of 2+ years experience in Quality Control in a GMP environment

Proficiency in eukaryotic cell culture, molecular techniques, operation of microscopes, and equipment calibrations (e.g., pH meters and balances)

An equivalent combination of education and experience may be considered.

Strong technical laboratory skills (e.g., pipetting, weighing, and measuring pH)

Experience with writing standard operating procedures

Familiarity with FDA, ICH, and EU Regulations and Guidelines

Involvement in continuous improvement initiatives and laboratory investigations

Proficiency in Microsoft Office suite applications Preferred:

Minimum of 2+ years experience in Quality Control in a GMP environment, preferably with experience in a microbiology laboratory

Experience with the following instrumentation: flow cytometers, qPCR, digital PCR, multimode plate readers

EOE/ADA

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