Biotech Quality Assurance Specialist
The successful candidate will have a strong background in biopharmaceutical quality control and experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Key Responsibilities:
* Perform analytical testing of various products, including raw materials and Validation
* Ensure the quality of tasks/services provided by self
* Contribute to team completion of milestones associated with specific projects or activities within team
* Plan and perform analyses with great efficiency and accuracy
* 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
* Participate in audits, initiatives and projects that may be departmental or organizational in scope
* Review protocols and perform assay validation and equipment qualification/verifications when required
Requirements:
* 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
* 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
* Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls)
What We Offer:
* Contract role - Hourly rate €28 - €33 per hour
* Minimum 12 month contract
* On site role
* Day role