Website RX2 Solutions
RX2 Solutions
Company : RX2 Solutions
TITLE: QC Manager
TYPE: Direct Hire
LOCATION: Apex, NC
ONSITE/REMOTE/HYBRID: Onsite
START DATE: January 2026
The QC Manager leads all analytical (chemistry and microbiology) activities supporting sterile 503B manufacturing. They guide the laboratory through startup (equipment and personnel), oversee method execution, uphold data integrity, and ensure testing is delivered with speed and accuracy. This is a hands-on role. The operation is lean, and the work requires someone who is as comfortable rolling up their sleeves in the lab as they are directing strategy and oversight.
This environment moves quickly. Success depends on a strong scientific foundation, reliable organization, and a 'get-things-done' mindset that keeps testing flowing whilst minimizing laboratory errors.
KEY RESPONSIBILITIES
- Lead daily QC laboratory operations across chemistry, microbiology, and environmental support.
- Execute and oversee testing for identity, potency, sterility, endotoxin, particulate matter, and other 503B release requirements.
- Actively participate in hands-on lab work when needed to support throughput and maintain timelines.
- Support method qualification, equipment setup, calibration, and readiness activities.
- Ensure data integrity, proper documentation, and compliance with cGMP analytical standards.
- Partner closely with QA and the Quality Site Head to align testing schedules with batch release needs.
- Validate sampling plans, testing protocols, and lab workflows to meet regulatory expectations.
- Contribute to laboratory build-out by verifying equipment placement, workflow efficiency, and operational suitability.
- Lead or support OOS, OOT, and lab deviation investigations; collaborate with QA on root cause and CAPA execution.
- Maintain training compliance for QC staff, including cGMP and required 503B development programs.
- Support the company's engagement with PDA, ISPE, and FDA 503B working groups.
- Bring urgency, clarity, and a practical problem-solving approach suited to a lean environment.
- Ensure facilitating an environment where Right First Time is the norm.
QUALIFICATIONS
- Bachelor's degree in Chemistry, Microbiology, or related scientific field.
- Five plus years of QC experience in pharmaceutical manufacturing; sterile preferred.
- Strong understanding of analytical cGMP expectations and data integrity requirements.
- Experience overseeing lab equipment qualification, calibration, and maintenance.
- Hands-on experience with OOS/OOT investigations and lab-based CAPA work.
- Comfortable being directly involved in bench-level testing and daily lab activity when needed.
- Thrives in a lean setting where initiative, ownership, and follow-through 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.