Sterility Assurance Senior Consultant

ProPharma Group; Raleigh (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

ProPharma Group is seeking a QA reviewer for a 2- to 3-month onsite engagement in Kansas City, KS. The role focuses on reviewing manufacturing, environmental monitoring, aseptic processing, deviations, complaints, and visual inspections to support product impact assessments and retrospective lot evaluations.

The successful candidate will have about 7 years of experience in sterility-related areas and will contribute to final reports and technical justifications.

Qualifications

• 7 years of experience in sterility, EM, aseptic processing and related investigations.
• Experience with product impact assessments and retrospective lot evaluations.

Responsibilities

• Execute lot-review activities in accordance with the approved protocol.
• Review manufacturing, environmental monitoring, aseptic processing, deviation, complaint, and visual-inspection data.
• Perform product-impact assessments and document conclusions.
• Identify recurring trends, adverse quality signals, and potential sterility-assurance concerns.
• Escalate findings requiring additional evaluation.
• Support development of technical justifications and final reports.

Skills

Sterility assurance

Environmental Monitoring

Aseptic processing

Investigations

Batch disposition

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Location: Kansas City, KS (onsite)

Duration: 2-3 months

Scope: This consulting role will perform detailed review of manufacturing, environmental monitoring, aseptic processing, deviation, complaint, and visual inspection data to support product impact assessments and retrospective lot evaluations. Duties include:

• Execute lot-review activities in accordance with the approved protocol.
• Review manufacturing, environmental monitoring, aseptic processing, deviation, complaint, and visual-inspection data.
• Perform product-impact assessments and document conclusions.
• Identify recurring trends, adverse quality signals, and potential sterility-assurance concerns.
• Escalate findings requiring additional evaluation.
• Support development of technical justifications and final reports.

Years of Experience: 7 years
Key Experience Required: Sterility assurance, EM, aseptic processing, investigations, batch disposition assessments

#LI-JH1 #LI-HYBRID

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.