About this role
This position is responsible for effectively performing Quality Assurance functions in accordance with standard operating procedures for solid dosage and soft-gel products, including finished bulk. The QA Lead manages activities on the assigned shift and adjusts task assignments as needed to ensure adequate coverage across all manufacturing areas.
Day-to-day responsibilities include conducting AQL sampling inspections on finished bulk and third-party products, performing physical tests per SOPs, and completing daily and monthly equipment calibration verifications. The role also involves reviewing Quality Assurance Notices prior to submission and making second-level AQL decisions.
As a mentor to QA Inspectors, this role promotes a professional work environment, conducts training and cross-training, and reports any inspector-related issues to the Quality Assurance Supervisor. The Lead oversees Inspectors and elevates concerns while maintaining cleanliness and organization of the QA lab and workstations.
This position offers the opportunity to develop supervisory capabilities within a pharmaceutical manufacturing environment. The role requires flexible hours to support manufacturing schedules and a strong commitment to cGMPs, company policies, and QA SOPs.
Requirements
- Current QA Inspector with at least 4 years of experience at IVC or relevant QA experience.
- High School Diploma or equivalent required.
- 1 year of supervisory experience preferred.
- Strong team orientation with the ability to work effectively with others.
- Excellent interpersonal, communication, and people management skills.
- Strong math, verbal, and written communication skills with high attention to detail.
- Proficient in math, computer use, and documentation practices.
- Must be able to work flexible hours to support manufacturing schedules.
Responsibilities
- Manage QA activities on the assigned shift and adjust task assignments as needed.
- Ensure adequate QA coverage across all manufacturing areas and monitor attendance.
- Conduct training and cross-training for QA Inspectors.
- Serve as a mentor to Inspectors, promote a professional work environment, and report issues related to QA processes or personnel.
- Review Quality Assurance Notices (QA Holds) prior to submission.
- Make second-level AQL decisions and complete additional assignments as requested by the Quality Assurance Supervisor.
- Perform physical tests in accordance with standard operating procedures and conduct AQL sampling inspections on all finished bulk and third-party products.
- Complete daily and monthly equipment calibration verifications and ensure lab equipment is functioning properly with adequate supplies.
Benefits
- Opportunity to develop supervisory capabilities in a pharmaceutical manufacturing environment.
- Work with solid dosage and soft-gel products in a cGMP-regulated facility.
- Mentorship and cross-training opportunities for career growth.
- Equal Opportunity Employer with a professional work environment.
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