Senior Scientist

2 days ago

Dún Laoghaire, Dún Laoghaire-Rathdown, Ireland beBeeQuality Full time €60,000 - €80,000
Job Title

Senior Quality Control Analyst

Job Details:
  • Associate level position.
  • Contract employment type.
  • Science field.
  • Pharmaceutical Manufacturing industry.
Job Description:

The successful candidate will be responsible for planning and performing analyses with great efficiency and accuracy. This includes planning and performing multiple, complex routine/non-routine methods and procedures and a large variety of assays. The individual will report, evaluate, back-up/archive, trend and approve analytical data. Additionally, they will troubleshoot, solve problems and communicate with stakeholders. They will also 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, introduce new techniques to the lab, including method transfers, reports, validations and protocols, conduct lab investigations as necessary and coordinate LIMS data of commercial and import testing on site where applicable.

Responsibilities:

  • Plan and perform analyses with great efficiency and accuracy.
  • Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of assays.
  • 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.
  • Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
  • Conduct lab investigations as necessary.
  • Coordinate LIMS data of commercial and import testing on site where applicable.
Qualifications:

Bachelor's degree in a Science related field is required. At least 3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry are also necessary. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products is highly desired. Strong technical writing experience and updating SOPs is also desirable. Analytical techniques such as Compendial testing would be advantageous.

Requirements:

  • Bachelor's degree in a Science related field.
  • At least 3 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.
  • Strong technical writing experience; updating SOPs is desired.
  • Experience with analytical techniques such as Compendial testing would be advantageous.
The Successful Candidate Will

Be very proficient in the use of Microsoft Word, Excel etc. They should have strong communication and technical writing skills. The ideal candidate will be detail oriented, self-motivated with good troubleshooting and problem-solving abilities. A self-starter with capability of working on own initiative is also preferred. They should have strong teamwork skills. Proven track record of meeting deadlines is also expected.

Desirable Skills:

  • Very proficient in the use of Microsoft Word, Excel etc.
  • Strong communication and technical writing skills.
  • Detail oriented, self-motivated with good troubleshooting and problem-solving abilities.
  • A self-starter with capability of working on own initiative.
  • Strong teamwork skills.
  • Proven track record of meeting deadlines.

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