Senior QC Analyst (Micro)

Location:  Cork, Ireland Category: Quality

Description


BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. 

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
 

The Quality Control Sr. Analyst, under direct or minimal supervision, is responsible for performing Microbiological testing, review and report writing for In Process, lot release, environmental and utility monitoring to support on site activities and drug product release.


The Sr. Analyst will be responsible for performing testing compliant with cGMP guidelines. Work assignments will encompass performing and documenting activities from routine to semi-routine in nature, and requires the ability to recognize deviations from the accepted practice. The Sr. Analyst will be responsible for the timely completion of assignments. Good record keeping, organizational, written, and verbal communication skills are essential. The Sr analyst must be willing to work overtime and weekends as required.


Duties/Expectations:

Performs, under minimal supervision, microbiological testing including Environmental Monitoring, Water Sampling, Endotoxin, Bioburden, Identifications, Growth Promotion, were required.

Timely review of test data against defined criteria/specifications, SOPs, GMP guidelines.

Ability to prioritise workload and meet deadlines.

Quality and compliance driven, identifies any issue and helps resolve, solution focused

Excellent written English to support report writing, deviations, LIRs, CAPAs and change controls, SOP updates

Supports audits to ensure the laboratory areas are inspection-ready and provides SME skills

Interacts with other departments at BioMarin on a regular basis, deputise and represent the QC Microbiology team when required

Develops and maintains proficiency in a broad range of trained test methods.

Trains other analysts in areas of expertise.

Seeks, learns, and applies new job related training and knowledge and shares knowledge with coworkers.

Holds self and others responsible to abide by department and company policies and practices.

Leads by example demonstrating good behaviours in the laboratory environment.

Familiarity with cGMP, 21CFR, USP, EP and ICH regulatory requirements.

Flexibility to work in a dynamic environment

Familiarity with use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel.

Works independently as well in a team environment

Skills
3-5 years in a cGMP/GLP laboratory; quality control experience is preferred.

Ability to follow written instructions and to perform tasks with minimal supervision.

Demonstrate strong leadership skills through past work history.

Good written, verbal, and communication skills.

Strong documentation skills a must.

Education
B.S./B.A. in Science (major in microbiology-biochemistry-biomedical science), A Msc in a relevant degree is preferable.

3-5 years of relevant laboratory experience.
 
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.