Job Type: Perm
Job ID: JO-1908-19268
Consultant: Karen McHugh
Are you an senior QA/QC Analyst with 5+ years experience managing a team of Biochemistry, Bioassay and Sample Management Analysts.
If you have the relevant experience, please forward your CV to firstname.lastname@example.org for review or call 353 1 7978720 to discuss in confidence.
Analytical Group Leader - Biopharma - Cork
Our client is a leading Contract Research Organization (CRO), working with pharmaceutical, biotechnology and medical device sectors.
The primary purpose of this role is to lead and manage a team of Biochemistry, Bioassay and Sample Management Analysts to ensure that the team is operating at the highest quality and productivity standards, have high morale and retention, and the agreed customer requirements are entirely satisfied and that customer expectations are met or exceeded through effective leadership and quality operational management
This person will be the key point of contact for both the Team and also the client on a day-to-day basis.
Effectively coordinating and managing members of the team so that productivity, quality, documentation, work schedules, safety and housekeeping is run at maximum efficiency.
Responsible for ensuring that the client gets the best possible service by continually reviewing best practice in relation to both commercial and quality issues and ensuring 100% ethical work standards and GMP compliance.
Responsible for the development, coaching, motivation, and morale of team members through effective teambuilding and use of reward and recognitions systems celebrating team success.
Responsible for reviewing and approving all relevant documentation and technical data in a timely manner and ensuring that it communicated, documented, and filed accurately.
Responsible for ensuring that work is scheduled and cross training takes place so that the service levels agreed with the customer are achieved. Responsible for amending schedules as required.
Ensure that all analysts are trained and have completed training records for all activites and other training completed.
Responsible for carrying out performance appraisals with staff as part of the overall performance management programme within the organisation.
Responsible for continuous feedback to all members of their team on all items in relation to client or organisational requirements / changes.
Responsible for handling any customer related queries where necessary and liaising with their team and with personnel from other teams to problem solve these queries if needed.
Perform other duties as designated by Laboratory Management.
To assist in manufacturing investigations as required, in particular event, deviations and CAPAs, to help meet product release specifications and timelines.
To foster a culture of Lean and Continuous improvement within the department and with internal and external partners.
Performing all technical duties required to the correct standard and turnaround times.
To address group local audit findings.
To participate as required in any investigations associated with the team deliverables.
To perform routine and non-routine technical duties and various support activities as required by the client.
To collect metrics and measure productivity through agreed metrics
A Bachelor Degree or Masters Qualification or PhD Qualification in Biotechnology, Biopharmaceutical sciences or relevant biological or life science is required.
A good knowledge of HPLC, Stability, SDS-Page, IEF, CE, plus general laboratory skills (balance, pipette, cleaning, equipment management etc.) is required
Experience with LIMS systems is desirable.
At least 5 years of GMP industry experience
Excellent leadership skills and at least 2 years’ previous supervisory experience.
Analytical skills to troubleshoot laboratory issues are an asset.
Ability to quickly learn new processes.
Experience in aseptic techniques is required.
Ability to communicate clearly and to form strong working relationships with colleagues.
Willing to operate in a flexible manner and be able to switch priorities at short notice.
Organised, accurate, have strong documentation skills.
Passionate about quality and customer service.
Excellent attention to detail
Good communicator - easily communicate findings and recommendations to internal clients.
Permanent Full time position
Benefits include medical insurance, pension and life assurance.
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail email@example.com or phone +353-1-7978720
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