ALS Ely provides a broad range of testing and analytical services to a variety of Healthcare and Pharmaceutical companies across the country; primarily supporting the release of sometimes life-changing drugs. We continue to remain at the forefront of the testing services industry, building an enviable reputation and a very resilient business.
About the Position
The main aim of this position is to accelerate continuous improvement initiatives and aid preparations for future growth within the non-sterile microbiology laboratory. ALS seek a Technical Manager, another key stakeholder at site, to help drive focused efforts to firmly establish ALS as the UK’s leading contract laboratory for microbiological testing services.
Main Duties to include:
- Coordination, management and resolution of technical queries within the Microbiology laboratory (testing activities include Non-Sterile Microbiology, Endotoxin, Purified Water and Environmental Monitoring)
- CAPA management: Authoritative assistance with both laboratory and client troubleshooting
- Quality Management System (QMS) maintenance to ensure continued alignment with cGMP, regulatory expectations, legally effective compendia and industry best practice (specifically with respect to Microbial Testing activities)
- Providing hands-on training, mentoring and coaching for the microbiology teams and wider business
- Internal and external audit support
- Being a technical champion for continuous improvement throughout operations, laboratory processes and procedures
- Actively seek to increase productivity and reduce operational risks
- Encouraging client retention and securing additional business through leading technical support and the development of meaningful client relationships
- Identifying and reviewing new market and testing opportunities
- Being an active promotor for a culture which embraces the ALS Core Values
About you
To be successful in this role you will have:
- Educated to degree level in a biological subject and / or have significant experience in managing / coordinating pharmaceutical microbiology laboratories
- 5+ years within a GMP environment
- Significant Pharmaceutical Microbiology Experience (Sterile and/or Non-Sterile)
- Excellent written and verbal communication skills
- Excellent organization, analytical and numerical skills
- Enthusiastic & friendly disposition – ability to persuade and influence others
- Computer literate with good grasp of Microsoft Office & Outlook packages
- Attention to detail. Ability to prioritize varied workloads under pressure
- Commercial awareness
- US-FDA exposure and/or Medical Device Testing Experience advantageous
Looking for further details?
Please address your cover letter and resume to: Dan.Bradley@alsglobal.com
Any queries can be directed to Salvatore Munago.
For more information about ALS – W: www.alsglobal.com