QC Analytical Engineer

Position summary

The QC Analytical Engineer is responsible for performing and documenting routine and non‑routine analytical laboratory testing of raw materials, in‑process samples, bulk product, stability samples, and finished goods in a cGMP, FDA‑regulated manufacturing environment supporting personal care, dietary supplements, and prescription/OTC products. This role focuses on analytical method development, troubleshooting, and continuous improvement of test methods and instrumentation to ensure products consistently meet specifications, customer expectations, and regulatory requirements. The QC Analytical Engineer collaborates closely with Quality Assurance, Manufacturing, and R&D to support batch release, investigations, method transfers, and process improvements within PureTek’s quality system.

Key responsibilities

• Perform and document analytical testing (e.g., assay by HPLC/UPLC, identity, related substances/impurities, content uniformity, dissolution, pH, osmolality, viscosity, appearance) on raw materials, intermediates, in‑process, stability, and finished product samples using approved compendial and internal methods.
• Execute and support analytical method transfer, qualification, and validation activities, including protocol execution, data analysis, report preparation, and response to comments from QA or regulatory stakeholders.
• Own or support the day‑to‑day performance, calibration, and basic troubleshooting of analytical instruments (HPLC/UPLC, GC, dissolution, balances, pH meters), and coordinate vendor qualifications, PM, and repairs as needed.
• Review analytical data for accuracy, completeness, and compliance with specifications and cGMP requirements; promptly report out‑of‑specification (OOS), out‑of‑trend (OOT), or atypical results and participate in investigations, CAPAs, and root‑cause analysis.
• Support laboratory and manufacturing investigations by designing confirmatory or supplemental tests, evaluating chromatograms and instrument logs, and documenting findings in accordance with site procedures.
• Contribute to the creation, revision, and implementation of SOPs, test methods, validation protocols, forms, and related quality documents to ensure alignment with FDA, cGMP, and internal quality standards.
• Trend and interpret analytical results and instrument performance data to identify opportunities for method robustness improvements, cycle‑time reduction, and error‑proofing of QC workflows.
• Ensure all activities comply with cGMP, data integrity, and safety requirements, including proper sample handling, chain of custody, and logbook/electronic record management.
• Collaborate with Manufacturing, Planning, R&D, and QA to support production schedules, new product introductions, change controls, and technical transfers.
• Support internal and external audits and regulatory inspections by presenting data, explaining analytical methods and equipment, and demonstrating adherence to procedures and cGMP expectations.

Qualifications

• Master’s degree in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline required.
• 10 years of hands‑on test method development experience in a cGMP‑regulated pharmaceutical, biotechnology, or related manufacturing environment.
• Strong practical experience with chromatographic and related analytical techniques (e.g., HPLC/UPLC, GC, dissolution), including basic troubleshooting and data interpretation.
• Working knowledge of cGMP, FDA guidelines, and relevant compendia (e.g., USP) as they apply to QC testing, method validation, and documentation.
• Demonstrated ability to manage multiple priorities, meet tight timelines, and deliver high‑quality, right‑first‑time data in a fast‑paced manufacturing environment.
• Proficiency with MS Office and experience with LIMS, chromatography data systems, or other laboratory informatics tools is preferred.
• Strong problem‑solving, organization, and communication skills with the ability to work effectively in cross‑functional teams.

Physical and work environment

• Laboratory and production‑adjacent environment within an FDA‑regulated, cGMP‑compliant manufacturing facility, involving regular work with chemicals and active ingredients under established safety procedures.
• Ability to stand for extended periods, lift moderate weights (typically up to 25 lbs), wear appropriate PPE, and work with analytical instruments and computer systems for most of the workday.