I3 INFOTEK INC is hiring: Sr. Quality Manufacturing Operations Specialist in Bos
I3 INFOTEK INC, Boston, MA, US
Job Title: Quality Development Specialist – Contract (2 Years)
Location: Boston, MA
Managers Note: Not seeking someone with compliance experience. we need experience with Quality agreements with CMOs/Suppliers.
Job Summary:
We are seeking an experienced Quality Development professional with hands-on experience in small molecule manufacturing to support multiple projects within a fast-paced pharmaceutical environment. The ideal candidate will be a critical thinker , able to lead investigations, manage quality agreements with external partners, and ensure compliance with GMP regulations across drug substance and drug product manufacturing.
Key Responsibilities:
- Lead and support Quality Assurance (QA) activities in a small molecule manufacturing environment.
- Manage and review quality agreements with CMOs, suppliers, and vendors .
- Lead event investigations, root cause analysis (RCA), and CAPA implementation .
- Ensure compliance with GMP regulations across Phase 1-3 drug substance and drug product manufacturing.
- Review, update, and maintain batch records, deviations, and CAPAs .
- Collaborate effectively with cross-functional teams and provide clear written and verbal communication .
- Support multiple projects and teams , ensuring timely completion within defined objectives.
- Utilize Veeva QMS or similar quality management systems for documentation and tracking.
Required Qualifications:
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biochemistry, or related field .
- 2+ years of experience in Quality Development or Operational QA in small molecule manufacturing.
- Experience with CMOs, suppliers, or vendors , including managing quality agreements.
- Strong critical thinking and problem-solving skills .
- Working knowledge of GMP regulations for drug substance and drug product manufacturing.
- Experience in leading investigations, RCA, and CAPA .
- Proficient in Veeva QMS or similar systems.
- Excellent communication and collaboration skills .
Preferred Qualifications:
- Experience with biologics, gene therapy, or medical devices .
- Project management experience supporting multiple projects/teams simultaneously.