Location: Tory, NY
Job Type: Contract
Industry: Pharmaceutical/Biotechnology
Key Responsibilities
Develop qualification protocols & final reports for packaging components
Define test panels, acceptance criteria, and AQL/RQL levels for inspections
Work with vendors to evaluate defect trends and qualification needs
Interpret QC test results (no hands-on testing) and determine compliance
Draft and maintain material specifications for primary/secondary packaging
Support fill/finish and drug product packaging qualification
Must-Have Qualifications
Strong component qualification experience (pharma/biotech)
Protocol & technical report writing for packaging components
In-depth AQL (Acceptance Quality Limit) knowledge (required)
RQL (Reject Quality Limit) familiarity (strong plus)
Experience with syringes, vials, closures, and secondary packaging
Ability to collaborate cross-functionally (QC, Quality, Process Sciences)
Nice-to-Have
Experience in GMP environments (Tech Services/Process Sciences)
Knowledge of FDA/ICH/ISO guidelines
Bachelor’s degree in Science/Engineering
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