Overview

USAntibiotics, the only U.S. manufacturer of Amoxicillin products, is part of the Jackson Healthcare family of companies.  We’re always looking to add new talent to our teams, and we value diverse professionals who have strong leadership skills, align with our culture, and are committed to excellence.

The Manger, QC Laboratories leads Chemistry laboratory operations supporting solid oral dosage forms (tablets, capsules and powders). This role endures timely, accurate, and compliant testing of raw materials, in-process samples, finished products, and stability studies. The manager drives data integrity, operational efficiency, and regulatory compliance while fostering a culture of scientific rigor and continuous improvement. Provide specialized technical support within the Quality Control Laboratory as assigned. Provide leadership/training to less experienced staff, as assigned to assure efficient and valid analytical laboratory support.

Assist with supervisory duties in the absence of Management (including review and approval of analytical data per cGMPs and regulatory requirements). Perform analytical testing of all sample types as assigned.

ESSENTIAL RESPONSIBILITIES: 

 

Laboratory Operations 

Direct daily scheduling and prioritization of testing for raw materials, in-process, finished products, and stability samples to meet production timelines. 

Ensure timely review and approval of analytical data, certificates of analysis, and batch records to support product release and regulatory commitments. 

Maintain inspection readiness through robust documentation practices and adherence to SOPs. 

Perform technical duties in specialized area. Assist laboratory supervisors with tasks, as needed. 

 

Technical Leadership 

Oversee method transfers, verifications, and validations for solid oral dosage forms per ICH Q2 guidelines. 

Troubleshoot analytical issues such as chromatographic resolution failures, dissolution anomalies, and system suitability deviations. 

Approve validation protocols, reports, and stability study designs; ensure compliance with compendial standards (USP/EP). 

Recommend changes to methods and Lab operations as appropriate to help gain efficiency. 

Perform satisfactorily on all analysts’ qualifications studies, indicating technical proficiency. 

Plan, perform, and document non-routine tests (or special studies) and investigations. 

 

Compliance & Data Integrity 

Enforce cGMP, 21 CFR Parts 210/211, and Part 11 requirements across all lab operations. 

Implement ALCOA+ principles for data integrity in electronic systems (LIMS, CDS) and paper records. 

Lead investigations for OOS/OOT results, root cause analysis, and implement effective CAPAs; trend data for continuous improvement. 

Document all results in accordance with cGMPs and written procedures. 

Interpret analytical results correctly, notifying Senior Management promptly of both situations that indicate analytical issues and manufacturing or product issues. 

Serve as technical resource during Regulatory inspections and internal audits as required. Also, conduct internal audits and self-inspections as required. Provide information to outside vendors and technical representatives in a professional manner. 

 

People Management 

• Recruit, train, and develop QC Analysts and Senior Analysts/Chemists; maintain training matrices and competency assessments. 
• Foster a culture of accountability, engagement, and scientific excellence through coaching and perf