- BBBH771828 Dec 11, 2020 Competitive
QC Analyst position available with a biopharma in Cork. This role will look at many different types of testing, including chemistry and micro backgrounds. Days role and 4 cycle shift role available
Excellent opportunity for a QC analyst coming from chemistry, bio or microbiological backgrounds to join an excellent Biopharmaceutical based in Cork. For these opportunities, and more in Microbiology, Bioassay and Chemistry, message me, Julieann Fitzpatrick, on Linked in, or email firstname.lastname@example.org. I'd be more than happy to have a chat.
Reporting to the QC Team Leader, the primary role of the QC Analyst is to provide support to internal and external customers by providing quality testing and delivering results in accordance with GMP standards. Ensuring our products are safe for patient use and fit for purpose.
The QC Operations Team is divided into 3 sub-teams QC Analytical; QC Microbiology and QC In-Process. The role could potentially lie within the QC Analytical or QC In-Process sub-teams depending on experience of the candidate and requirement. Shift work is required for the QC In-Process team only..
The role potentially will cover both Analytical and Microbiological testing including but not limited to the following:
- Analytical testing performed by the lab incl: HPLC, SDS, FTIR, UV, plate based assays; capillary electrophoresis
- Microbiological testing performed by the lab incl: Utilities; Bioburden; Endotoxin
- Testing of finished product, raw materials, packaging and stability
- Perform primary review of QC raw data and trend results
- Prepare protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agencies
- Develop, optimize, validate and troubleshoot analytical test methods
- Draft QC SOPs
- Act as technical resource (SME)and train other analysts in areas of expertise
- Evaluate results against defined acceptance criteria
- Conduct and document laboratory investigations to completion
- Maintain the laboratory in an inspection-ready state
- Interact directly with regulatory agency inspectors during audits
- Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary
- Excellent communication skills both written and verbal
- Customer focus; takes personal responsibility for speed; quality and accuracy of delivery
- Self-motivated and ability to work under pressure
- Team Leadership - active participation team development and continuous improvement including standard work and 5S
- Successful track record in achieving goals as part of a team within a growing, dynamic environment
- Demonstrated adaptability and flexibility to support a growing organisation
* Ability to work independently and meeting established timelines.
* Comfort with coordinating the activities with other staff members.
* Comfort with working in a team environment
* Knowledge of cGMPs.
B.S. in a scientific discipline with 3+ years of relevant laboratory experience.
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.
353 (0) 21 2300300