This is a part time role. ~10 hours per week. Hybrid work flexibility.
Duties:
- Provides QA operations oversite and support for laboratory operations including review and approval of protocols and reports, master batch records, executed batch records and QC data verifications under management guidance.
- Active involvement in support of CAP inspections from regulatory authorities.
- Coordinates, prepares and approves the release process documentation for our products.
- Assists with the management of deviations, change controls, corrective and preventive actions for operations: Provides support for Lot release activities and Management Reviews.
- With management guidance interfaces Works collaboratively with Quality Control to assist to resolve quality system issues, compliance needs, OOS investigations, environmental excursions, and assay validation needs.
- Provides support as needed in the following capacity: review of technical input on investigations, deviation, non-conformances, and change controls.
- Supports continuous improvement quality initiatives to be inspection ready.
- Effectively participates in Quality Assurance system process improvements and associated training as needed.
Qualifications:
- Requires a Bachelor’s/Master’s Degree with 5+ years of experience working in a FDA/EMA regulated environment with an understanding of quality laboratory operations.
- Must be able to communicate effectively (verbal/written) to multiple disciplines and levels within an organization.
- Ability to adjust to changing environment, setting priorities for self and be self-motivated. should be able to function independently or within a team with minimal direct supervision.