Responsibilities:
- Representative for NPI activities and routine Product meetings
- Assist with activities related to QC projects and/or QC tasks within Site projects
- Plan and perform non-core testing related to NPI activities
- Create and approve protocols, sample plans, SOP and documentation related to NPI
- Representative responsible for Method Validation and Transfers co-ordination and readiness
- LIMS data coordination of non-core (NPI) activities.
Duties:
- With a high degree of technical flexibility, work across diverse areas within QC
- Plan and perform multiple, complex routine/ non-routine methods and procedures across a large variety of assays.
- Report, evaluate, back-up/archive, trend and approve analytical data.
- Troubleshoot, solve problems and communicate with stakeholders.
- Initiate and/or implement changes in controlled documents.
- Train others as necessary
- Participate in audits, initiatives and projects that may be departmental or organizational in scope.
- Write protocols and perform assay validation and equipment qualification/ verification.
- Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
- Interact with outside resources.
- APPX data files and randomisation memo to facilitate data analysis.
- LIMS data coordination of commercial and import testing on site where applicable
- Provide technical guidance.
- May contribute to regulatory filings.
Qualifications:
- Bachelor's degree in a science discipline.
- 3 - 5 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
- Strong background in Chemistry and Analytical testing is required.
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.