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Quality Control Microbiology

  • Job reference: 923216
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 04/01/2019

Orion group are recruiting a Senior Quality Control Microbiology on behalf of our multinational biotechnology client based in Ireland- 12-month contract

Under minimal supervision, the successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers and verifications, sample and data management and equipment maintenance. This role is for an experienced and technically strong associate who will spend 90% of their work day performing testing. The successful candidate would contribute to the team by ensuring the quality of the tasks/services provided by self and contribute to the completion of milestones associated with specific projects or activities within the team. This role will support manufacturing operations, as such some extended hours, shift and weekend work may be necessary as required.

Basic Qualifications
* Bachelors degree in a science discipline
* Biopharmaceutical QC experience in a microbiology lab
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products

Preferred Qualifications
* Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Environmental Monitoring, Rapid Microtechniques, Microbial Identification, Media prep, Water Sampling.
* Understanding and application of principles, concepts, theories, and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning
* Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
Skills
* Take initiative to identify and drive improvements
* Excellent verbal and written communication skills
o Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
o Presentation skills
o Escalate issues professionally and on a timely basis
* Decision-Making skills
* Teamwork and Coaching others
* Negotiation and Influence skills
* Problem-solving skills
o Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
o Ensures compliance within the regulatory environment
o Develops solutions to technical problems of moderate complexity
o Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
o Interprets generally defined practices and methods
o Able to use statistical analysis tools to perform data trending and evaluation
* Project Management and organizational skills, including ability to follow assignments through to completion

Competencies
* Technically strong background in microbiology and aseptic manufacturing
* Experience in LIMS, Chah ange Control, Trackwise, SAP and EDMQ an advantage
* Experience with Regulatory inspectors and interacting with inspectors desirable
* Demonstrated ability to work independently and deliver right first time results
o Works under minimal direction
o Work is guided by objectives of the department or assignment
o Follows procedures
* Refers to technical standards, principles, theories and precedents as needed
* May set project timeframes and priorities based on project objectives and ongoing assignments.
* Recognizes and escalates problems
o Demonstrated leadership and communication skills
o Auditing documentation and operation process
o Demonstrated ability to interact with regulatory agencies


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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