Job Title: Senior Quality Assurance Associate
Job Description:
We are seeking a highly skilled and motivated Senior Quality Assurance Associate to join our team. As a key member of our quality assurance group, you will be responsible for ensuring the quality of tasks and services provided by self and contributing to the completion of milestones associated with specific projects or activities within the team.
Key Responsibilities:
* Quality Control 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
* Manage all sample management activities related to NPI activities throughout the site
* Create/own and approve protocols, sample plans, SOP and documentation related to NPI QC Representative responsible for Method Validation and Transfers coordination and readiness
* Responsible for their own training and safety compliance
* Sample shipments and temperature monitoring activities for NPI activities LIMS data coordination of non-core (NPI) activities
* Plan and perform analyses with great efficiency and accuracy
* Report, evaluate, back-up/archive, trend and approve analytical data
* Create APPX data files and randomisation memo to facilitate data analysis
* 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
Required Skills and Qualifications:
* Bachelors degree in a science discipline
* 2-3 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
* Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories
* Deepens technical knowledge through exposure and continuous learning
* Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
* Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
* Anticipates and prevents potential problems
Benefits:
This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.
The ideal candidate will have strong analytical skills, attention to detail, and excellent communication skills. They will also be able to work independently and as part of a team, with minimal supervision.
Others:
Skills: Quality Control