Website RX2 Solutions
RX2 Solutions
Company : RX2 Solutions
TITLE: QA Manager
TYPE: Direct Hire
LOCATION: Apex, NC
ONSITE/REMOTE/HYBRID: Onsite
START DATE: January 2026
The QA Manager is a key leader within a lean, fast-moving 503B sterile manufacturing operation. This role oversees batch release, investigations, CAPA, documentation control, and the daily use of MasterControl. It calls for someone who brings steady judgment, strong scientific grounding, and a practical mindset that turns decisions into action. This is an environment where clarity, ownership, and follow-through matter.
KEY RESPONSIBILITIES
- Lead batch record review and product release activities.
- Manage investigations, deviations, change controls, and CAPA with disciplined, timely execution.
- Oversee documentation accuracy and MasterControl workflows.
- Maintain cGMP training requirements for all employees and ensure alignment with 503B expectations.
- Ensure Quality leadership completes the FDA/PDA 503B compounding course.
- Support engagement with PDA, ISPE, and FDA 503B working groups.
- Contribute to inspection readiness and support regulatory interactions.
- Bring a strong sense of urgency and accountability to daily quality operations.
- Along with the Quality Team, ensure training, and the ethos of quality/Right First Time is instilled into the entire company culture.
QUALIFICATIONS
- Bachelor's degree in Chemistry, Biology, or related science.
- Five plus years of QA experience in pharmaceutical manufacturing; sterile preferred.
- Strong understanding of cGMP and 503B outsourcing requirements.
- Hands-on experience with investigations, CAPA, deviation management, and change control.
- Proficiency with electronic quality systems, ideally MasterControl.
- Comfortable working in a lean environment where initiative and decisive action are essential.
EOE STATEMENT
We are an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.