Key Responsibilities:
- Author component qualification protocols, final reports, and related documentation.
- Lead efforts for component identification, specification development, and qualification of drug product packaging materials.
- Work closely with QC, Quality Assurance, Process Sciences, and other internal teams to define test panels and acceptance criteria.
- Establish and apply appropriate Acceptance Quality Limit (AQL) and Risk Quality Limit (RQL) levels for incoming component inspections.
- Evaluate QC data and defect trends to determine component suitability-no hands-on testing required.
- Coordinate with vendors and suppliers to support component qualification and address defect trends or non-conformance.
- Contribute to the creation and maintenance of technical specifications for primary and secondary packaging components.
- Support qualification efforts aligned with fill/finish operations and drug product packaging systems.
Required Qualifications:
- Proven experience in component qualification processes within regulated pharmaceutical or biotech environments.
- Strong background in technical writing, including drafting protocols and writing comprehensive technical reports.
- In-depth knowledge of AQL (Acceptance Quality Limit) - required.
- Working knowledge of RQL (Reject Quality Limit) - strongly preferred.
- Familiarity with primary and secondary packaging components, including vials, syringes, closures, trays, and other single-use packaging materials.
- Demonstrated experience interpreting QC defect data and evaluating vendor-supplied materials.
- Solid understanding of GMP compliance, regulatory expectations, and documentation standards.
- Ability to collaborate cross-functionally with technical, quality, and supply chain teams.
Preferred Qualifications:
- Prior experience supporting Technical Services or Process Sciences in a GMP manufacturing environment.
- Familiarity with FDA, ICH, and ISO regulatory guidelines related to packaging materials.
- Bachelor's degree in a scientific or engineering discipline (e.g., Chemistry, Chemical Engineering, Materials Science, or related field).