What are the responsibilities and job description for the QC Lab Analyst position at Assure Infusions?
Company Description
Assure Infusions is addressing the critical IV fluid supply chain challenges by building a cutting-edge automated facility in Bartow Florida. Our mission is to support the healthcare system by providing consistent access to essential medical products and a reliable supply of IV fluids to hospitals and healthcare facilities. Assure Infusions is dedicated to innovation and operational excellence in the medical manufacturing field.
Job Summary
The QC Chem Lab Analyst I is responsible for performing advanced quality control testing of raw materials, in-process samples, and finished pharmaceutical products to ensure compliance with regulatory standards and internal specifications. This role requires expertise in analytical chemistry techniques such as HPLC, A.A. S, UV-Vis, FTIR, and titrations.
The QC Chem Lab Analyst I will independently execute and troubleshoot complex test procedures and laboratory equipment. Adhere to cGMP, GDP, GLP, SOPs, Protocols and other technical documents and all applicable safety and quality regulations. Additionally, the position supports method validations, investigations, and continuous improvement initiatives.
This is a fulltime onsite position in Bartow, Florida.
Key Responsibilities
Quality Control and Compliance
- Perform and oversee quality control testing of compounded sterile products.
- Assist with data review
- Daily calibration of laboratory equipment (pH meter, balances etc.)
- Ensure adherence to USP <797>, USP <800>, and other applicable standards.
- Assist with regulatory audits and inspections.
- Develop and implement quality control procedures.
Operations Management
- Manage laboratory resources, including equipment and supplies (tracking inventory)
- Procurement of laboratory reagents and chemicals
- Coordinate with other departments to improve overall product quality.
- Assist with production needs when required (sampling etc.)
Documentation and Reporting
- Review and maintain batch records, certificates of analysis, and test results.
- Ensure proper documentation of quality control activities.
- Interpret laboratory data
- Contemporaneous laboratory notebook documentation
- Entering data into log various logbooks
Required Qualifications
- Education: Bachelor’s degree in pharmacy, Chemistry, or related field (or equivalent experience).
- Experience:
- Minimum 3 - 5 years in a GMP laboratory (preferred)
- Experience in a 503B outsourcing facility or equivalent sterile compounding environment is an advantage (preferred)
- Skills & Knowledge:
- In-depth knowledge of cGMP, FDA regulations, GDPs, and USP standards.
- Strong understanding of sterile compounding processes and quality control methods (preferred)
- Excellent leadership and communication skills and overall team mentality
- Proficiency in Laboratory Information Management Systems (LIMS).
- Ability to interpret and apply complex regulatory requirements.
Physical Requirements
- Ability to sit or stand for long periods and ambulate independently around lab/office space.
- Manual dexterity to handle lab equipment and supplies.
- Occasionally lift up to 20 pounds and reach overhead.
Working Conditions
- Exposure to pharmaceutical ingredients and chemicals.
- Work performed in office and cleanroom environments with strict aseptic techniques.
Equal Opportunity Statement
Assure Infusions, Inc. is an Equal Opportunity/Affirmative Action Employer – Protected Veterans/Disabled. We provide equal opportunity to all individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, GINA, and age.