QC Sterility Analyst

5 months ago

Cork, Ireland BioMarin Full time

QC Analyst- Sterility Team – 6 months

Exciting new role in the newly approved sterility test lab within the QC team at BioMarin. This role will be focused on supporting primary component packaging, microbiology and sterility testing support the new Drug product facility in BioMarin.

QC Sterility are a high performing team-based group. The team is dynamic and works cross functionally on site with various other departments supporting routine testing, investigations and project work and providing SME guidance. Members of the team are empowered to make decisions.

A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.

The role of the QC analyst will include executing testing of primary packaging components for use in the Drug Product facility and routine test in the QC Sterility team to support drug product operations.

SKILLS/ KNOWLEDGE/ BEHAVIOURS

Microbiological testing performed by the lab including:Growth Promotion and Biological Indicators Perform testing and review of primary packaging component testing Prepare protocols, summaries, and reports— 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, Engineering, 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. Using systems such as Labware LIMS, MODA and Veeva Quality Docs

EDUCATION

B.S. in a scientific discipline with 1+ years of relevant laboratory experience.

EXPERIENCE

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 Experience using quality system such as Veeva Experience working with primary or secondary packaging an advantage

  • QC Analyst

    6 months ago

    Cork, Ireland Westbourne IT Global Services Full time

    Working as part of a Lean Lab team-based structure he role will involve the use of the classical analytical technologies including Raman, FTIR, KF, in addition to a broad range of modern analytical techniques including HPLC, GC, ICP-AES, ICP–MS, and wet chemistry techniques. The QC analyst will also be required to engage and fully participate in daily...

  • Quality Control Analyst

    1 month ago

    Cork, Ireland RT Lane Ltd Recruitment Full time

    R.T. Lane Recruitment are currently recruiting for QC Analysts to work with a pharmaceutical company based in Cork. This is a 12-month contract with strong potential for extension. **Please note that candidates must hold the correct working visa for Ireland and be currently living in Ireland as my client cannot offer visa assistance** The candidate must have...

  • QC Analyst – Viral Vector

    6 months ago

    Cork, Ireland BioMarin Full time

    Who We Are 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...

  • Micro Analyst

    4 weeks ago

    Cork, Ireland PE Global Full time

    Description: PE Global is currently recruiting for a QC Micro Analyst on behalf of a leading biotech company based in Cork. This is an initial 12-month contract and a 2-shift cycle role. Overview: The candidate must have superior technical knowledge of analytical techniques and knowledge of related laboratory equipment in the area of microbiological,...

  • QC Laboratory Apprentice

    6 months ago

    Cork, Ireland BioMarin Full time

    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,...

  • QC Analyst

    2 months ago

    Cork, Ireland SGS Full time

    Job Description Main Purpose of Role Testing of pharmaceutical substances raw materials and drug substances in a GMP environment in accordance with clients' procedures and quality systems. The main focus will be GC and HPLC analysis, along with a range of other analytical techniques as required. Key Accountabilities Receive training from SGS...

  • QC Analyst

    2 months ago

    Cork, Ireland SGS Full time

    Job DescriptionMain Purpose of RoleTesting of pharmaceutical substances e.g. raw materials and drug substances in a GMP environment in accordance with clients' procedures and quality systems. The main focus will be GC and HPLC analysis, along with a range of other analytical techniques as required.Key AccountabilitiesReceive training from SGS and client and...