Associate QC Manager - Micro
Summary: Assists in the management of the the QC Microbiology team and provides critical microbiology support to manufacturing and facilities. This role has a strong emphasis on compliance.
Duties and Responsibilities
- Manages a team of laboratory analysts within the QC microbiology department involved in the analysis of raw materials, intermediates (in process) and bulk drug substance in a cGMP regulatory environment.
- Manages the environmental monitoring programme, including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas
- Design and coordinates the microbiological validations as needed for drug substance, in-process controls and buffers.
- Support manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice on QC related topics as needed.
- Participate in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate.
- Coordinates laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
- Manages CAPAs and Change Controls
- Takes full accountability for team leadership
- Interaction and management of internal and external customers
Education and Experience
- BS/BA in Microbiology or closely related field with 5+ years’ experience in microbiology lab, preferably in the pharmaceutical or biotech industry with 3+ years’ experience in a leadership role in microbiology laboratory management.
- Passionate about Microbiology and have a keen eye for attention to detail and enjoy troubleshooting complex quality issues
- Agile and eager to work in fast pace environment where organizational change attitude is both championed and encouraged
- You are comfortable in a leadership role, with high emotional intelligence and ability to identify hidden strength in your team
- Organizational citizenship is a personal goal and value.
We need someone with BSc/BA in Microbiology or related field with 6+ years of relevant experience, experience in microbiology lab, preferably in the pharmaceutical or biotech industry with 3+ years’ experience in a supervision role in microbiology laboratory management. We are looking for an individual who has a proactive and collaborative leadership style.
Reach out to Aisling Murray on 087 4671309 or at firstname.lastname@example.org