QC Senior Associate - (QC sample management)
Berkley Group View all jobs
- Dublin
- Contract
- Full-time
- Execute sample management activities across the site - sample distribution, LIMS logging, shipment receipt.
- Perform Stability Program related activities such as pulling stability samples and study initiations.
- Create/own and approve protocols, sample plans., SOPs, training manuals.
- Perform SAP, LIMS and CIMS functions/ transactions within the sample management remit
- Out-of-hour responder for sample management equipment (fridges /freezers / incubators)
- Responsible for their own training and safety compliance.
- Sample shipments and temperature monitoring activities.
- LIMS data coordination of commercial and import batches.
- Management and maintenance of the Site Inventory of Reference Standards, Assay Controls, Training and Verification samples.
- QC Representative for NPI activities and routine Product meetings as required.
- Bachelor's degree in a Science related field is required.
- 4+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, where 2 - 3 years of specific sample management/ stability program experience is desirable.
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
- Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues.
- Auditing documentation and operation process.
- Demonstrated ability to interact with regulatory agencies.