Katalyst Healthcares & Life Sciences
Location: Bedford,MA, USA
Date: 2024-11-21T08:36:35Z
Job Description:
Responsibilities:
- Review and approve supplemental logs, charts and other documents in support of cGMP Operations.
- Review batch records for accuracy and completion prior to final release of product.
- Perform product releases specifically fills and intermediates lots.
- Coordinate product releases with distributors and customers as needed.
- Review and approve incoming materials for release.
- Provide quality assurance support of investigations including: nonconformance and root cause analysis.
- Perform quarterly walkthrough audits of manufacturing and packaging, complete audit activities as assigned.
- Issue, review and reconcile batch records as needed.
- Assist in the maintenance of the Quality System.
- Participate in project teams and perform other related duties as assigned.
- Assignments are defined by objective and required outcome.
- Exercises judgment within defined parameters and policies; expected to propose practice and policy improvements. Job requires maintenance of up-to-date knowledge of all applicable international regulation and regulatory guidance.
Requirements:
- Bachelor's Degree or equivalent experience.
- Medical device quality system management experience or an acceptable combination of education and experience will be considered.
- Internship experience may be considered.
- Knowledge of GMP, FDA, ISO requirements.
- Requires computer competence, including experience with database and Microsoft Office.
- Excellent written and verbal communication skills.
- Desired Experience, Knowledge, and Skills.
- Experience working in a GMP/ISO environment.
- Good presentation and organization skills.
- Attention to details.
- Capable of executing tasks per defined policies and procedures to resolve routine issues.