QC Analyst

Assure Infusions; Bartow (FL); On-site; USD 80,000 - 105,000; Full time

Job summary

Assure Infusions in Bartow, FL, seeks a QC Analyst to perform routine and non-routine analytical testing in a GMP-regulated pharmaceutical manufacturing environment. The role requires a strong background in small molecule analytics, compendial methods, and laboratory quality systems.

You will support investigations, CAPAs, and deviations, with responsibility for data integrity, documentation, and cross-functional collaboration with QA, Manufacturing, and Validation teams.

Qualifications

• Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Biology, Biochemistry, or related field.
• Minimum 5 years of experience in GMP pharmaceutical QC or related regulated laboratory.
• Strong background in small molecule QC analytics, compendial testing, and data integrity.

Responsibilities

• Perform routine and non-routine QC analytical testing per approved procedures and GMP.
• Coordinate raw material sampling, testing, and release activities.
• Investigate deviations, CAPAs, and OOS events with proper documentation.
• Review data for accuracy and ensure compliance with ALCOA+ and GMP.

Skills

GMP QC

Technical writing

Data integrity

Independent worker

Education

Bachelors in Chemistry

Tools

Empower

LIMS

Electronic QA systems

Job description

About Us

Assure Infusions specializes in IV bag production, operating out of a fully automated, state-of-the-art facility in Bartow, Florida. Our mission is to deliver high-quality, safe, and reliable infusion products through innovation, precision, and strict adherence to regulatory standards.

Position Summary

The QC Analyst is responsible for performing and supporting quality control laboratory testing in a GMP-regulated pharmaceutical manufacturing environment. This role requires a strong background in small molecule analytical chemistry, compendial testing, raw material testing, wet chemistry, and laboratory quality systems.

Key Responsibilities

QC Analytical Testing

Perform routine and non-routine QC analytical testing in accordance with approved procedures, specifications, compendial methods, and GMP requirements.

Responsibilities include, but are not limited to:

• Perform raw material sampling, receipt, testing, and release activities.
• Conduct analytical testing for raw materials, in-process materials, finished products, stability samples, cleaning validation samples, and other QC samples as required.
• Execute wet chemistry and compendial testing in accordance with USP/NF, EP, JP, or other applicable standards.
• Perform testing using analytical techniques including:
  • High Performance Liquid Chromatography (HPLC)
  • Atomic Absorption Spectroscopy (AAS)
  • Flame Photometry
  • Total Organic Carbon (TOC) Analysis
  • Manual Titrations
  • pH, conductivity, osmolality, appearance, identification, assay, limit tests, and related analytical methods
• Prepare standards, reagents, mobile phases, titrants, buffers, and sample preparations in accordance with approved procedures.
• Perform standardization of titrants and verification of reagents, reference standards, and laboratory solutions.
• Review analytical data for accuracy, completeness, compliance, and adherence to specifications.
• Accurately document all testing activities in laboratory notebooks, worksheets, LIMS, Empower, or other applicable GMP systems.
• Ensure test results are scientifically sound, traceable, complete, and compliant with ALCOA+ data integrity expectations.

Investigations, CAPAs, Deviations, and OOS Support

Support laboratory investigations and quality events associated with analytical testing and QC operations.

Responsibilities include:

• Initiate, support, and close laboratory investigations, deviations, atypical results, invalid assays, and out-of-specification (OOS) investigations.
• Assist with root cause analysis for analytical failures, instrument issues, procedural errors, sample handling concerns, or laboratory process gaps.
• Evaluate potential product impact associated with laboratory events.
• Write clear, scientifically justified investigation summaries and conclusions.
• Support development and implementation of corrective and preventive actions (CAPAs).
• Track CAPA effectiveness and ensure assigned actions are completed on time.
• Work cross-functionally with QA, Manufacturing, Validation, Engineering, and other departments as needed.

Qualifications

• Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.
• Minimum of 5 years of experience in a GMP pharmaceutical, biotechnology, medical device, or other regulated QC laboratory preferred.
• Strong background in small molecule QC analytical chemistry.
• Experience with raw material testing, compendial testing, product release testing, and wet chemistry.
• Hands-on experience with analytical laboratory instrumentation listed above.
• Working knowledge of USP requirements and GMP laboratory expectations.
• Experience with laboratory investigations, deviations, CAPAs, and OOS/OOT events.
• Strong technical writing skills, including experience drafting or revising GMP procedures and laboratory documentation.
• Strong understanding of data integrity principles and GMP documentation practices.
• Ability to work independently, prioritize work, and manage multiple testing activities in a fast-paced QC environment.

Preferred Qualifications

• 7 or more years of QC analytical chemistry experience in a GMP pharmaceutical environment.
• Experience in sterile pharmaceutical manufacturing, parenteral products, 503B outsourcing, or small molecule drug product manufacturing.
• Experience with Empower, LIMS, electronic document management systems, or electronic quality management systems.
• Experience with method verification, method transfer, validation support, or analytical troubleshooting.
• Experience supporting regulatory inspections, client audits, internal audits, or laboratory remediation activities.
• Strong familiarity with USP monographs, general chapters, reagent preparation, reference standards, and compendial interpretation.
• Experience with stability testing, raw material qualification, cleaning validation testing, and laboratory trending.